Sterling Diagnostic Imaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Sterling Diagnostic Imaging, Inc. makes
Sterling Diagnostic Imaging, Inc. manufactures digital radiographic systems, including direct radiography units and mammography equipment such as the Ultra-Vision Mammography Detail and Fast Detail models. Their portfolio also includes a PACS (Picture Archiving and Communication System) solution, a laser imager for medical imaging, a direct radiography operator console, a dry film printer, and networking systems for medical imaging infrastructure.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. Their systems are listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
Sterling Diagnostic Imaging Direct Radiography Ref K973206
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Iisys Pacs System Ref K980220
Regimes: 510(k) Registry: 510(k)Helios Laser Imager 1417 Ref K973028
Regimes: 510(k) Registry: 510(k)Iirad Directray Operator Console Ref K980970
Regimes: 510(k) Registry: 510(k)Raven Dry Printer Ref K972660
Regimes: 510(k) Registry: 510(k)Linx Networking System Ref K964250
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sterling Diagnostic Imaging, Inc. have in the registry?
The registry currently lists 7 devices for Sterling Diagnostic Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sterling Diagnostic Imaging, Inc.'s devices?
Among its 7 most recently registered devices, Sterling Diagnostic Imaging, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Sterling Diagnostic Imaging, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Sterling Diagnostic Imaging, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sterling Diagnostic Imaging, Inc. in the registry?
The most recently registered devices listed for Sterling Diagnostic Imaging, Inc. include STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY, ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL, IISYS PACS SYSTEM and HELIOS LASER IMAGER 1417.