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MHRA 04003
Comparative Specifications of
General Radiography Systems
Comparative Specifications of
General Radiography Systems
MHRA and the Device Evaluation Service
Policy statement
The Medicines and Healthcare products Regulatory Agency (MHRA) Device
Evaluation Service provides evaluation of medical devices available within the UK.
This report contains the summaries of evaluations that represent the quantitative and
qualitative data obtained from one or more X-ray systems during a type test. The
manufacturers have been asked to ensure their devices are operating within
specification and therefore the results should be representative of any identical models
of this device. Evaluation data in the report does not take account of any
modifications to the device since the evaluation. Where data on other similar devices
have been included for comparative purposes, the data will usually be identical to
those originally published; any exceptions will be highlighted.
The MHRA Device Evaluation Service does not have access to any information held
by the Agency in its capacity as the Competent Authority for the UK, apart from any
information already in the public domain. The reports will contain data given by the
manufacturer on the regulatory status of their devices but apart from this, they are not
an indicator of the regulatory status of a product. Occasionally, the Device
Evaluation Service refers products to the regulatory arm of the MHRA for
consideration of breaches of the legislation governing medical devices. The Device
Evaluation Service plays no further part in any regulatory investigation that ensues
and does not have advance notification of any regulatory action that may follow.
The British Standards Institute has accredited KCARE to the ISO 9001: 2000 Quality
Standard. All KCARE tests are conducted with reference to national and international
standards for the safety and performance of medical equipment.
KCARE organises a number of user groups to discuss matters including the
evaluation programme in general and features specifically relating to each evaluation.
KCARE welcomes comments and suggestions on the evaluation programme and the
presentation of reports.
Centre
manager Neil Lewis, Centre Director
Programme
manager Martin Glasspool, MHRA Device Evaluation Service
Contents ......................................................................................................... 1
Abbreviations................................................................................................. 3
Introduction.................................................................................................... 4
Future developments .................................................................................................... 5
Vertical bucky.............................................................................................................. 20
Comparative specifications:
Universal systems for general radiography .............................................. 27
This report includes general radiography systems currently available in the UK and
will be updated as systems undergo any major changes or when new systems are
introduced to the market.
Suppliers are given the opportunity to check and comment on the report prior to
publication. The information provided has not been independently verified by
KCARE.
General radiography systems are comprised of several major components and the
purchaser selects the most suitable configuration for their requirements.
• table
• X-ray tube (ceiling supported or floor mounted) and generator
• tomographic facility
• vertical bucky.
This report contains data for the highest specifications of complete new systems
available, with details of other configurations available included. Suppliers may offer
alternative tables, generators, or tubes depending on the requirements of the
department.
If the supplier has not provided the requested information, ‘Information not supplied’
is shown.
Future developments
Philips Medical Systems plan to replace the Bucky Diagnost TS (floor mounted X-
ray tube and X-ray table system), with a new floor stand, the Bucky FS in 2004.
Siemens Medical Solutions have expanded their product range into digital
radiography with the option to purchase or upgrade to the Multix M range.
Wolverson X-ray Limited plan to launch the Arcoma fully integrated direct digital
system in 2005.
Notes:
a. Detailed specifications included in this report. Other systems listed are also available from the
supplier.
b. Zenith Medical Systems Ltd. supply England and Wales, Medstone International Ltd. supply
Scotland.
KCARE understands that Severn X-ray Supplies Ltd. also supply general radiography
systems in the UK and may be contacted directly for product information.
Tomography exposure Information not 0.4 / 4.0 with 30° 0.4 / 4.0 with 30° Information not
N/A
times (s) supplied 0.6 / 3.0 with 20° 0.6 / 3.0 with 20° supplied
-1 60 (stationary)
Grid: lines⋅cm 40 40 40 User has choice
43 (oscillating)
Ratio 10:1 12:1 12:1 12:1 User has choice
Focal length (cm) 180 150 150 150 User has choice
Information not
Grid movement Option No Yes Yes
supplied
Information not Information not
Removable grid No No Option
supplied supplied
No (VE)
Bucky tilt Yes (on SG100) No Option No
Yes (VT)
Tilt range (°) - 20 to + 90 N/A - 20 to + 90 N/A - 30 to + 90
Name of X-ray tube Shimadzu Circlex Varian A197 Varian, Dunlee or Toshiba Varian, Dunlee or Toshiba
Focal spot size(s) (mm) 0.6 and 1.2 0.3 and 0.8 0.6 and 1.2 0.6 and 1.2
Generator name Shimadzu UD150L-30EX SX00XX00 2 TUBE CPI Indico 100 CPI Indico 100
Generator (kW) Information not supplied 50 or 65 Information not supplied Information not supplied
Generator console Information not supplied Digital display Information not supplied Information not supplied
Report Publication
Report Name Number Date
Small Field Digital Mammography Systems. MHRA 03142 Mar 2004
Instrumentarium Imaging - Now Part of GE
Medical Systems Delta 32
Comparative Specifications of Computed Radiography MHRA 03140 Dec 2003
Systems for General Radiography. Edition 2.0
A full list of all KCARE reports may be accessed on the KCARE website
(www.kcare.co.uk).
MHRA evaluation reports are published by the Medicines and Healthcare products Regulatory Agency, an Executive
Agency of the Department of Health. They are available free of charge to the UK National Health Service (NHS),
and are for sale to commercial organisations and other interested parties. A free catalogue of available reports can be
obtained from the Orders Department, or downloaded from the MHRA web site:
http://www.medical-devices.gov.uk
Ordering
Send your order to the address given below, stating the number, title and quantity of each report required. Your
reports will be despatched by second class post the following working day. If you are not a representative of the NHS,
you will be invoiced separately. Non-NHS customers are reminded that it is not possible to offer refunds for reports
ordered in error.
Orders Department
Room 1207
Medicines and Healthcare products Regulatory Agency
Hannibal House
Elephant and Castle
London
SE1 6TQ
Enquiries