Prism Imaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Prism Imaging, Inc. makes
Prism Imaging, Inc. manufactures ultrasound imaging workstations and software solutions for cardiology, including dedicated viewing stations for stress echocardiography and image review, as well as specialized cardiology workstations for diagnostic analysis.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance pathway. These devices are intended for use in the United States.
Catalogue
Vista Viewing Station Ref K904975
Regimes: 510(k) Registry: 510(k)Cine'view - Stress Echo & Image Review Ref K904976
Regimes: 510(k) Registry: 510(k)Cine/View Plus - Cardiology Workstation Ref K904977
Regimes: 510(k) Registry: 510(k)Software Program Used W/Prism Products Ref K904978
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prism Imaging, Inc. have in the registry?
The registry currently lists 4 devices for Prism Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prism Imaging, Inc.'s devices?
Among its 4 most recently registered devices, Prism Imaging, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Prism Imaging, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Prism Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prism Imaging, Inc. in the registry?
The most recently registered devices listed for Prism Imaging, Inc. include VISTA VIEWING STATION, CINE'VIEW - STRESS ECHO & IMAGE REVIEW, CINE/VIEW PLUS - CARDIOLOGY WORKSTATION and SOFTWARE PROGRAM USED W/PRISM PRODUCTS.