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    42 views9 pages

    2935 001

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    javo599

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    © All Rights Reserved
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    DNV Management System Certificate Carecate No, Intl caricton Oat: Vals unt 348216-2097- ALUSANAPS Rov 02 ‘ry 2015, 3 2028 This is to certify that the quality system of: Codonics Incorporated 17991 Englewood Drive, Middleburg Heights, OH 44130 USA has been found to conform to the Quality Management System standard ISO 13485:2016/NS-EN ISO 13485:2016 This certificate is valid for the following scope The Design, Manufacture, Servicing, Sales and Distribution of Imaging and Patient Safety Devices for the Medical industry. For he ieuig ote: DNV Product Assurance AS Bh Syne, Negi, ey Sar SO, cart ‘eae tera oms aden as scum Conteaon Ayoone, ale cong mayer i Cait ak ‘ats Baty: DAY Prot sate AS, Vera, 1985 Hak Ney, Te +4767 57880 wc iceasinssoruse é Se fey U.S. FOOD & DRUG ADMINISTRATION Certificate No. 5995-2-2020 CERTIFICATE TO FOREIGN GOVERNMENT In order to allow the importation of United States products into foreign countries , the U.S. Food and Drug Administration (FDA) certifies the folowing Information concerning the produc(s) to be exported isted below: Name of Product(s) Name of Manufacturer/Distributor, Address See Attached List See Attached List (One Page) (One Page) {ihe product(s) described above (and the manufacturing/disttibution site(s) which produces/distributes itis subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act Its certified that the above product(s) may be marketed in, and legally exported from, the United States of America at this me, The manufacturing plant(s) in which the product(s) is produced & subject to period inspections. The last such inspection showed thal the plant(s), at that time. appeared to be in substantia ‘compliance with current good manufacturing practice requirements for the product(s) listed above Sincerely, CS at ines, COR Cesar A. Perez, PhD, Director DRP2: Division of Establishment Support Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food and Drug Administration, DHHS This certificate is valid from February 21, 2020 to February 20, 2022 Se U.S. FOOD & DRUG Certificate No. $995-2-2020 Certificate to Foreign Government - Name of Manufacturer/Distributar Attachment Page 1 of 1 ‘CODONICS, INC. 17991 ENGLEWOOD OR Middleburg Heights, OH USA 46130 Name of Manufacturer CODONICS. INC. 17931 ENGLEWOOD OR. Cleveland, OH USA 44130 Name of Distributor CODONICS, INC. 17991 ENGLEWOOD OR. Cleveland, OH USA 46130 END OF MANUFACTURERIDISTRIGUTOR LIST- Se U.S. FOOD & DRUG Certificate No, 6995-22020 Certificate to Foreign Government - Name of Product(s) Attachment Page 1 of 1 Name of Owner Operator Nidoburg Hogs, OF USA 44130, Name of Wanutacturer 5, INC 17991 ENGLEWOOD OR, Cheval, OH USA 44130 Mame of Distibutor ODONICS, NC. 17991 ENGLEWOOD OR Covel, OH USA £4130 Name of Product(s) (ORIZON MEDICAL MULTIMEDIA DRY IMAGER adelsContguations Gi Lange Format Coon, Gay CLRAD Ma Foxmat Coby, s Mosnon Format Coo, ay Scale, Fn OSRAD Mult Format roy Seale SF Smal Format Colo, Gray Seale, Fm 6 (1497 Th 1 Sil {62 Dusl oput Mult Format, Gray Seal, Fém AL Mecical Long Fl imager (14% & 1451) ‘CODONICS SAFE LABELING SYSTEM (SL) adel .8-500/560), $1 §-SOOPISE0P SIS Sale Label System Aniston Toa! (A) (ll SLS applcabie) DIRECT VISTA THERMAL FiLM FILM RADIOGRAPHIC Dec Vista Bie Blue Filn@x10, {1n14. 1417, 436, 14081 Doct Vita Bue: (OVE) Far-Ba30. 14417 Direc ta Rue-5 (OVO) Fim x1, 11114, out? 14438, 1951 Diet Vis Car Finsx10, 14x Dace! Vita Wie Fk &, Aa, $4404. Ye nt Se M Muli Fazal, Gay Scale, Fn XXX, Paint of Gare Sto —--FNO OF F UCT List Document Ref: DoC2020Rev 01 EODONIES | Lecteration of Conformity Page: 1 of 5 EC DECLARATION OF CONFORMITY 1) Manufacturer (Name, department): Codonics, Incorporated Address: 17991 Englewood Drive, Middleburg Heights, Ohio 44130. USA. and 2) European authorized representati ‘Address: ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS; (on product labels printed as: CEpariner4U, ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS www.cepartnerdu.com/ 3) Product(s) (name, type or modeVbatch number, etc): image Printers, Disc Publishers, Medication Safety Systems, and accessories / recording media, see Appendix 4) The product(s) as noted in appendix and described above in conformity with: Title Document No. Medical Device Directive 93/42/EEC Restriction of the use of certain 2011/65/EU hazardous substances (RoHS) 1SO 13485:2016/NS-EN ISO 13485:2016 | 245216-2017-AQ-USA-NA-PS Rev. 1.0 IEC 60601-1-2:2014 4th Edition MDD 93/42/EEC 5) Additional information (conformity procedure, Notified Body, CE certificate, etc.) Conformity assessment procedure for CE marking: Medical Device Directive, Annex VII Middleburg Heights, Ohio s October 14,2020 Alan DeSantis, VP, Regulatory Affairs and QA ORIGINAL ON FILE WITH CEpartner4U , Esdoornlaan 13, 395108 Maar. The Nethertands. www.cepartner4u.com: 900-001-010.01 6 CODONICS Declaration of Conformity Document Ref; DoC2020Rev 01 Page: 2 of 5 Appendix Date: 2019-11-15 List of Devices Updated 2020-10-14 [, First Date of DEVICE NAME MODEL RISKCLASS / RULE ° CE Marking HORIZON MEDICAL MULTIMEDIA | Gi Large Format Color, Gray | Glass T-Rule 12 ‘oa77372002 vee ORY IMAGER, Horizon. | Scale, Fim (image printer) CONFIGURATION 2. xx or higher ‘Gi-RAD Mutt Format Color, VEC 6060%-1-2:2074 4th Ed i SF, XL Gray Scale, Fim VEC 60601-1.2:2014 Ath Ed GS, G1, C2 GS Large Format Gray Scale Model Designation is Logo Badged on |g sna oxmat Color, Gray ‘each product Chassis | Scale, Fim G (1417) Three input Single Media 1 Single Input Multi Format, Gray Scale, Film {G2 Dual Input Mult Format, Gray Scale, Film XL Medical Long Film imager (1436 & 1451) ‘SRA Madical imager GZ par HRGZT-SRIFOT | SRM Imager Grass TRule 72 OBFITIOTS ‘SRM Modical imager Gs part HRGsT-SRMLO2 (Image printr) CNFG 8.x or higher GE Medical Multtmedia ImagerXX | Models eluded Gi, GS, SF, XL_| Class T-Rule 12 OATBO0T ONFG 8.xx or higher Long Film Imager (image printer) 1EC 60601-1-2:2014 ath Ed Cl, SF, XL IEC 6060%-1-2:2014 th Ed GS, G1, C2 TORO Fim CReator TGRo Fim CReaior Glass TRule 12 OBEAOOT CNFG 8.0« or higher (mage printer) PRO Imager KK par #120-S-0007 PROMAGEr ‘Class FRue TZ O71 72007 PROImager-XX-plus: part 4120-9-0003 ((mage printer) 711112007 CNFG 8.2x or higher ‘Virtua Series Medical Disc Publisher and] Virtua, Virtua C, Vitua E, Glass T- Rule 2 ‘O6TETT2006 Image Manager (CDIDVD Disc Publisher) | ius xR IEC 60601-1-2:2014 ath Ed Virtua XR Medical CD/DVD Dise (Medical mage Data | 07/1112007 Publisher IEC 60601-1-2.2014 ath Ed Storage Device) Declaration of Conformity Document Ref: DoC2020Rev 01 Page: 3 of 5 First Date of DEVICE NAME MODEL RISKCLASS / RULE CE Marking Sao Labsing Stem 51S SLS-S00; SIS HO, SISK [Css FR? ——]oawa7o77 818-50, Pott Cre Saton | Mian Data (Pos) Management Devic) Safe Label Stem Adinisatie Teo! |PC Sotware oavos0t1 TEC 6601-12014 an Ea DAYLIGHT Wodaiy Pir Suton] PC Stars Cass Rue? JOST (Medical Image Data storage Devin ‘CODONICS OPTICAL DISC MEDIA Medical Grade CD-R Disc Media | Class 1-Rule 1 ~ | 4970172073 Modal Grade BVO-RDC |Genaes money Neda Varios 20s" OVOIOVE, OVS 8 Dec Vas Bus Caran — [ORS RET osrraamas var (Radars Fim) Dred VsaBlies | lrdcopyMeda) | 98202018 DvP, CVP (ated a6 Cob and Gray |e Vita Paper, Dect Vita oar2004 Sale white Fins), Ghvoma Vista Paper Chroma Veta nto Fire cart72004 CVTICVE(TranspareneyColorFims) | chroma Vista Transparency rater pa tits at |atlo Ova ota car172008 Dros Vita 146,961 DirectVista Long Film: perer2oo7 SRM media of Various sizes of SRM B10, 11°14", 18x17" [Class T-Rule 7 (06/17/2019 OVCOVaDVETIOVES Radiographic |xedica (Harécopy Meda Fim) moa Fin Oger RX Wi Tragg Fim | PROImager OVE Ta and [Cane TRUE on FT x10 RadogapneFim) | areopy Meds Wi aig Fin Ex, AIT Toue and — [ass TFT oT Taaa7 Various sizes of BVCIDVB (Rasonapic | Sea" Medealimanng Fim | sracopy Meda) Fim) and DVP, OVP (sed as Cole and. Re 1° Medica! imagng Gray Scale WhioFims).cvriove [SuyseaePape DvP (Transparency Ctr Fins) Ses Ove indo Ad, Be0, 1316, 6x7, an 14999, 1481 ico Wedel gi Fim CR im CRealo OVE TORT | Oa FRI aaSTOOT ‘and 8x10 (Radiographic Film) | (Hardcopy Media) G covons Declaration of Conformity Document Ref: DoC2020Rev 01 Page: 4 of 5 Note: ‘SRM Products are Horizon imagers and media manufactured by Codonics and Labelled /Packaged Tor SRM Romania {PROTEC Products are Horizon imagers and meia manufactured by Codonics and Labelled /Packagod Tor PROTEC Medical Systems “GE Heatheare Pr for GE Healthcare are Horizon imagers and media manufactured by Codonics and Labeled /Packaged * iGRco iim Products are Horizon imagers and media manufactured by Codonics and Labelled /Packaged for iCReo Incorporated Product ALIAS CROSS REFERENCE. Tinage importer Viewer Image Storage Server Codonies teary GCO VIEW TGs STATON —Codentes tiny OX ‘Stora Daa Sto {infinity ROSS) Toshiba ROSS (CRRS 108/28) Siemens SRO Codonles tity Raw Bata Tadonieslniniy-t or Codon Bi ‘Server WAGERS ALIAS Codonies-——Codonies-—«Codonics_—« Cadet’

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