U.S. Food & Drug Administration 10903 New Hampshire Avenue: Silver Spring, MD 20993

Toshiba Medical Systems Corporation +BOVBSZ

℅ Orlando Tadeo, Jr.
Manager, Regulatory Affairs
Toshiba America Medical Systems, Inc.
2441 Michelle Drive
TUSTIN CA 92780
Re: K173090
Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: II
Product Code: IYN, IYO, ITX
Dated: December 20, 2017
Received: December 21, 2017
Dear Mr. Tadeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. The general controls provisions of the Act include requirements for annual
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding
and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.
We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.
U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.02.03
Silver Spring, MD 20993
www.fda.gov
Page 2 - Orlando Tadeo, Jr. K173090
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
'PS
Robert Ochs, Ph.D.
Director
Division of Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement below.
510(k) Number (if known)

,
Device Name
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
Indications for Use (Describe)
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Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (1/14) 4EKISJ PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY

1. SUBMITTER’S NAME:
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara‐shi, Tochigi‐ken, Japan 324‐8550

2. OFFICIAL CORRESPONDENT
Naofumi Watanabe

3. ESTABLISHMENT REGISTRATION:
9614698

4. CONTACT PERSON:
Orlando Tadeo, Jr.
Manager, Regulatory Affairs
Toshiba America Medical Systems, Inc
2441 Michelle Drive
Tustin, CA 92780
(714) 669‐7459

5. Date Prepared:
December 20, 2017

6. TRADE NAME(S):
Diagnostic Ultrasound System
Aplio i900 Model TUS‐AI900 Software Version V2.4

7. COMMON NAME:
System, Diagnostic Ultrasound

8. DEVICE CLASSIFICATION:
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90‐IYN [per 21 CFR 892.1550]
Ultrasonic Pulsed Echo Imaging System – Product Code: 90‐IYO [per 21 CFR 892.1560]
Diagnostic Ultrasonic Transducer – Product Code: 90‐ITX [per 21 CFR 892.1570]
2441 Michelle Drive, Tustin, CA 92780 / 800.421.1968 / medical.toshiba.com

Page 1 of 6

9. PREDICATE DEVICE:

Product Marketed by 510(k) Number Clearance Date
Aplio i900/i800/i700 Diagnostic Toshiba America K163702 May 30, 2017
Ultrasound System, V2.1 Medical Systems
(Main Predicate Device)
Boris Platform Ultrasound System Philips Ultrasound, Inc. K030455 March 13, 2003
Vivid E9 GE Healthcare K131514 July 12, 2013
GE EchoPAC GE Healthcare K120221 March 30, 2012
Aplio Artida (SSH‐880CV), V3.2 Toshiba America K140729 May 23, 2014

Medical Systems
Voluson E8 GE Healthcare K162269 October 3, 2016
HD11 Philips Ultrasound, Inc. K062247 August 18, 2006

10. REASON FOR SUBMISSION:
Modification of a cleared device

11. DEVICE DESCRIPTION:
The Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and
Aplio i600 Model TUS‐AI600, V2.4 are mobile diagnostic ultrasound systems. These systems are
Track 3 devices that employ a wide array of probes including flat linear array, convex linear array,
and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

12. INDICATIONS FOR USE:
The Diagnostic Ultrasound Systems Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio
i700 Model TUS‐AI700 and Aplio i600 Model TUS‐AI600 are indicated for the visualization of
structures, and dynamic processes with the human body using ultrasound and to provide image
information for diagnosis in the following clinical applications: fetal, abdominal, intra‐operative
(abdominal), pediatric, small organs, trans‐vaginal, trans‐rectal, neonatal cephalic, adult cephalic,
cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo‐skeletal (both
conventional and superficial) and laparoscopic.

13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aplio i900/i800/i700, Diagnostic Ultrasound System,
V2.1, K163702, marketed by Toshiba America Medical Systems. The Aplio i900 Model TUS‐AI900,
Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and Aplio i600 Model TUS‐AI600, V2.4
function in a manner similar to and is intended for the same use as the predicate devices. The
subject device is a compact diagnostic ultrasound system that implements the latest technologies.

Page 2 of 6

Device Aplio Aplio Artida Vivid Voluson Boris HD11 Comment

i900/i800/ i900/i800/ V3.2 E9/EchoE8 Platform
i700/i600 i700 (V2.1) PAC Ultrasound
V2.4 System
510(k) Subject K163702 K140729 K131514/ K162269 K030455 K062247
Clearance Device (Main K120221
Number Predicate)
3D Yes* No Yes *LA and
Wall LV RV RV analysis
Motion Analysis Analysis are new
Tracking features
Z‐Score Yes No Yes
Mitral Yes No Yes
Valve
Analysis
MPI Yes No Yes

Improvements to previously cleared functions:
Device Aplio Aplio Comment
i900/i800/i700/i600 i900/i800/i700
V2.4 (V2.1)
Thin Slice Imaging Yes Yes Slice Thickness Control
Feature Improvement(s)
Auto Volume Measurement Yes Yes Feature
Improvement(s)
CHI Yes Yes High Frame Rate/4D
SMI Yes Yes iSMI/4D
ADF Yes Yes 4D
Shear Wave Elastography Yes Yes Feature Improvement(s)
(ECG Sync Acquisition)
Sensor 3D Yes Yes Feature Improvement(s)
(ECG Sync Construction)
Smart Fusion Yes Yes Feature Improvement(s)
2D WMT Yes Yes Use with 2D Array

transducers
Shear Wave Elastography Yes Yes New clinical applications
Shear Wave Dispersion Map Yes Yes Feature Improvement(s)
PSI‐30VX Yes No New transducer


Page 3 of 6

Device Aplio Aplio Comment

i900/i800/i700/i600 i900/i800/i700
V2.4 (V2.1)

PLI‐2002BT Yes No New transducer

PVT‐482BT Yes No New transducer

PVT‐675MVS Yes No New transducer

PLI‐705BX Yes No New transducer

PLT‐1202BT Yes No New transducer

PEI‐512VX Yes No New transducer

14. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21
CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the
IEC 60601‐1, IEC 60601‐1‐2, IEC 60601‐2‐37, IEC 62304, NEMA UD 3, NEMA UD 2, and ISO 10993‐1
standards.

15. TESTING
Risk Analysis, Verification/Validation testing conducted through bench testing and clinical
evaluation which are included in this submission demonstrates that the requirements for the new
and improved features have been met.

Performance Testing – Assessment of 3D WMT
Multiple studies were performed to confirm that the function of 3D Wall Motion Tracking on the
Aplio i900/i800/i700 is substantially equivalent to the predicate devices with regard to the
following:
Left Ventricle Analysis: The subject device demonstrated equivalency in terms of volume
measurement feature (EDV/ESV/EF) and strain measurement feature (Area Change Ratio, Global
Longitudinal Strain, Global Circumference Strain, Global Radial Strain).
Left Atrium Analysis: The subject device demonstrated equivalency in terms of volume
measurement feature (EDV and ESV or Vmax and Vmin) and strain measurement feature (Global
Area Change Ratio, Global Longitudinal Strain and Global Circumference Strain).
Right Ventricle Analysis: The subject device demonstrated equivalency in terms of strain
measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference
Strain). Additionally, the volume measurement feature (EDV/ESV/EF) demonstrated a
Correlation coefficient (r) >= 0.90 with n=11 as compared to the predicate function, Vivid E9
(K131514) with GE EchoPAC (K120221).

Representative clinical images were also obtained using the 3D WMT features LV analysis, LA
analysis, RV analysis and Quad Chamber Tracking. It was concluded that the 3D WMT
implemented on the subject device enables the cardiac wall trace (initial contour setting) and

Page 4 of 6

the local wall motion tracking, providing wall motion information analysis and display, cardiac
volume measurement, cardiac function analysis and display of the three analysis features
simultaneously.

Performance Testing – Assessment of Auto‐EF
An assessment of workflow improvement was conducted on a group of three volunteers and it
was concluded that the full‐assist function for tracing the contour line reduced operation time
over that of the predicate device to obtain the EDV/ESV/EF and Global Longitudinal Strain.
Additionally, a clinical evaluation of this function was conducted and it was demonstrated that
Auto‐EF performed as expected in presenting appropriate clinical measurements.

Performance Testing – Assessment of 3D ACM
A study conducted using a pulsating flow phantom demonstrated that flow volume
measurement met performance specifications as expected.

Performance Testing – Assessment of Z‐Score Measurement
A bench study was conducted using previously acquired fetal ultrasound data to demonstrate
that the subject function calculate and provide the correct Z‐score for cardiac structure such as
Aortic valve ,Pulmonary valve based on the pre obtained value of femur length (FL), biparietal
diameter (BPD) or gestational age (GA) using fetal echocardiography.

Performance Testing – Assessment of MPI Measurement
A bench study was conducted using a Doppler phantom with a water cistern and it was
demonstrated that the function can (1) correctly measure velocity at an ROI to provide a graph
of time variation of the velocity TIC, by using the 510(k) cleared TDI function, (2) correctly
measure the time duration between two points manually indicated on TIC, and (3) calculate MPI
correctly from the two time durations designated on TIC.

Performance Testing – Assessment of Mitral Valve Analysis (MVA)
A side‐by‐side comparison of seventy (70) patients with varying degrees of mitral valve
conditions was conducted using a double‐intubation protocol to evaluate the basic function and
performance of the MVA in vivo, with regard to the visualization of the mitral valve anatomy,
surrounding structures, the mitral valve spatial relationship to the aortic valve and including the
annulus, anterior/ posterior leaflets, leaflet segmentation, coaptation line and commissures.
Assessment included evaluation of image quality, measurement, work flow improvement and
interoperator variability. Results of the study demonstrated that the subject function is
substantially equivalent to the predicate device with regard to all assessment criteria.
Additionally, a cardiac phantom was scanned and analyzed by the Aplio i900/MVA software and
by a Computed Tomography (CT) system. The MVA software output measurements were
compared to equivalent parameters using the CT images. As a result of this study it was
determined that the MVA software was able to meet the specified criteria for each of the MVA
measurement items as compared to the CT image measurements.

Page 5 of 6

Performance Testing – Assessment of 4D Imaging for 2D Array transducers
Bench testing was conducted using a phantom to demonstrate that the function correctly
depicts the shapes and flow within the phantom. Additionally, clinical images were obtained on
volunteers to demonstrate that the function performs as intended.

Additional performance testing, using phantom and volunteer studies, was conducted to assess
improvements to existing features including Slice Thickness Control, Auto Volume
Measurement, High Frame Rate CHI, 4D CHI, 4D ADF/SMI, iSMI, ECG Sync Acquisition (Shear
Wave Elastography), ECG Sync Construction (Sensor 3D), Smart Fusion, 2D WMT (2D Array
transducer use), Shear Wave Elastography and Shear Wave Dispersion Map. Results of all these
studies demonstrated that the improvements met specifications and performed as intended.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document,
“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Document” issued on May 11, 2005, is also included as part of this submission.
Additionally, testing of this device was conducted in accordance with the applicable standards
published by the International Electrotechnical Commission (IEC) for Medical Devices.

16. CONCLUSION
The Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and
Aplio i600 Model TUS‐AI600, V2.4 is substantially equivalent to the predicate devices. The subject
devices function in a manner similar to and is intended for the same use as the predicate devices,
as described in the labeling. Based upon the bench testing, clinical evaluation, acquisition of
representative clinical images, successful completion of software validation, application of risk
management and design controls, it is concluded that this device is safe and effective for its
intended use.

Page 6 of 6

U.S. Food & Drug Administration 10903 New Hampshire Avenue: Silver Spring, MD 20993

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Toshiba Medical Systems Corporation +BOVBSZ

Dear Mr. Tadeo:

U.S. Food & Drug Administration

510(k) Number (if known)

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

FOR FDA USE ONLY

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Vivid E9 GE Healthcare K131514 July 12, 2013

GE EchoPAC GE Healthcare K120221 March 30, 2012

Aplio Artida (SSH‐880CV), V3.2 Toshiba America K140729 May 23, 2014

HD11 Philips Ultrasound, Inc. K062247 August 18, 2006

Device Aplio Aplio Artida Vivid Voluson Boris HD11 Comment

2D WMT Yes Yes Use with 2D Array

Shear Wave Dispersion Map Yes Yes Feature Improvement(s)

PSI‐30VX Yes No New transducer

Device Aplio Aplio Comment

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