Chair: Roland Richter, Siemens Medical Solutions USA, Inc.
Vice Chair: Paul Biggins, Toshiba America Medical Systems, Inc.
Industry Director: Stephen Vastagh
Assistant: Pam Larbig
Contents:
- Product Scope
- Description of Markets for These Products
- Section Organization
- Section Objectives, Programs, and Activities
- Section Liaisons
Product Scope
All equipment, accessories, and devices used in the application of X-rays for medical diagnostic, dental, inspection, and nondestructive testing or analysis purposes. (Note that relative to Section membership, manufacturers of products which may be incorporated into or used as an accessory with a medical diagnostic imaging system and are also used in essentially the same form in other non-medical applications are not eligible. These products include but are not limited to:
X-Ray Systems:
Radiography
Mobile Radiography
Digital Radiography
Computed Radiography
RF
Mammography
Digital Mammography
Angiography
CT
Tomographic
Cardiac
Stationary C Arms
Mobile C Arms
Vascular
Fluoroscopy
Digital Fluoroscopy
Urological
Combination Systems that include one of the above systems (e.g. CT-PET, etc.)
X-Ray Equipment:
Generators
Tables: Tilting, Bucky, G.U. and Special Procedures
Tubestands: Floor to ceiling, ceiling mount
Mobile and portable X-ray units
Fluoroscopes
X-ray tubes and housings
Spot film devices
Image Intensifier tubes
Mammography Units
Rapid Film Changers
Film holders, cassette changers
C, U, and L Supports
Digital Imaging Equipment
Head stands
CT & X-Ray Tomography
Automatic X-ray exposure controls
Timers
Grids, Buckys
Cameras-TV, Cine, Spot, Video format (Single and Multiple)
Image Display Devices (e.g. CRT monitor, etc.)
Recorders
Accessories:
Rotor Controllers
X-ray tube heat monitors
Localizing & positioning devices (i.e. lasers, etc.)
Automatic Processors
Manual Processors
Film drying equipment
Film holders
Film illuminators and view boxes
Stereoscopes
Film storage and retrieval equipment
Leaded X-ray protective devices
Cassettes
Screens
Stationary grids
Test, monitoring and instrumentation equipment
Description of Markets for These Products
Medical diagnostic X-ray imaging equipment is sold to hospitals, free standing imaging centers, group practices and individual physicians. General practitioners may purchase a chest unit while specialists such as cardiologists, urologists, diagnostic radiologists, purchase more complex or specialized equipment. All large manufacturers include the complete range of imaging products (Ultrasound, MRI, etc.), and are multinational.
Included among the diagnostic X-ray imaging equipment is mammography equipment. There are about 9,500 certified mammography facilities in the U.S. performing screening and diagnostic examinations. They are regulated by the Mammography Quality Standards Act. A recent significant technical development is full field digital mammography (FFDM). Digital mammography creates images that can be processed in a variety of ways to best visualize the variety of objects of interest, e.g. small calcifications and soft tissue lesions. Having images in digital form also facilitates telemammography. Thus, patients at remote locations can be screened and the images read/analyzed instantly by a radiologist located in an urban medical center. Lack of radiologists at remote locations made such services inaccessible by many patients. A negative development in mammography is the increasing shortage of radiologists willing to specialize in mammography. The high profile of mammography has increased the liability while the decreasing reimbursement makes it economically unattractive for a radiologist to specialize in mammography; the new capabilities of equipment can somewhat compensate for this shortage.
Also included is computed tomography (CT). The CT equipment is evolving to increase the efficiency of the procedure and the quality of the images. Increasing attention is being paid to assure that the radiation dose administered to patients during CT scanning is as low as possible while creating usable images. Dose management thus is becoming a high priority objective of users and manufacturers alike.
Computed radiography and digital radiography are growth areas in this section. Another development is the increasing integration of radiology information systems with image management and hospital information systems.
Section Organization
X-Ray Imaging Product Section: Chair, Roland Richter, Siemens Medical Solutions
Technical & Government Relations Committee: TBA
Market Data Program Statistical Committee: Daniel VanHyhuis, Philips Medical Solutions
CT Group: Chair - Paul Biggins, Toshiba Medical Systems; Vice-Chair - John Jaeckle, GE Healthcare
X-Ray Tube Subcommittee: Chair - Dennis Runnoe, Varian Medical Systems
Mammography Subcommittee: Chair - John Sandrik, GE Healthcare; Vice-Chair - Jacqueline Gallet, Carestream Health, Inc.
Cardiovascular & Interventional Group: Chair - Judith Regn, Siemens Medical Solutions
IEC SC62B TAG: Chair - William Gerber, (Consultant); Stephen Vastagh, TAG Secretary
NEMA/SCA&I Joint Working Group on Cardiac Fluoroscopic Performance: Chair - Stephen Balter, SCAIR
Section Objectives, Programs, and Activities
- Monitor and provide industry input and representation to the FDA Advisory Committee on Quality Assurance in Mammography and the Technical Electronic Product Radiation Safety Standards Committee activities.
- Maintain the NEMA X-Ray Statistical Reporting Programs and the NEMA Specific Industry Forecasting Program. Collect and report in the aggregate industry shipments and orders.
- Coordinate collective actions on members issues and their impact on industry.
- Develop industry positions for presentation to other associations, groups, regulatory books both in the domestic and international markets.
- Develop and coordinate industry positions on FDA guidances, standards and regulations.
- Maintain the NEMA X-Ray standards and evaluate and respond to standardization needs of the industry.
- Provide Secretariat to the Technical Advisory Group for IEC 62B.
- Provide input to the U.S. Technical Advisor to SC62B on proposed IEC standards. Provide experts to appropriate working groups for IEC standards development activities impacting medical diagnostic X-Ray equipment.
- Provide Secretariat to the NEMA/SCA&I Joint Working Group on Cardiac Fluoroscopic Performance to maintain the NEMA XR-21 Standard.
- Coordinate manufacturers participation in various AAPM, ACS and similar activities and committees. Liaison between manufacturers and user organizations.
Section Liaisons
Key Meetings Scheduled for 2006
The Section and most of the groups regularly meet during the week of RSNA and AAPM's annual meetings. Additional meetings and teleconferences are called as needed.
