Realtimeimage, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Realtimeimage, Inc. makes
Realtimeimage, Inc. manufactures imaging systems under the IPACS brand, including the IPACS PRISM-5.0, IPACS CARDIO, IPACS PRISM, and IPACS ORTHO. These devices are designed for real-time medical imaging in cardiology, orthopedics, and general diagnostic applications, providing intra-operative visualization and guidance.
The company’s portfolio consists of Class II medical devices, each authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are based in the United States.
Catalogue
Ipacs Prism-5.0 Ref K050298
Regimes: 510(k) Registry: 510(k)Ipacs Cardio Ref K042781
Regimes: 510(k) Registry: 510(k)Ipacs Prism Ref K030751
Regimes: 510(k) Registry: 510(k)Ipacs Ortho Ref K041366
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Realtimeimage, Inc. have in the registry?
The registry currently lists 4 devices for Realtimeimage, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Realtimeimage, Inc.'s devices?
Among its 4 most recently registered devices, Realtimeimage, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Realtimeimage, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Realtimeimage, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Realtimeimage, Inc. in the registry?
The most recently registered devices listed for Realtimeimage, Inc. include IPACS PRISM-5.0, IPACS CARDIO, IPACS PRISM and IPACS ORTHO.