Medasys, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Medasys, Inc. makes
Medasys, Inc. manufactures digital nuclear imaging systems and image processing software, including the Pinnacle Image Processing System, designed for diagnostic and therapeutic nuclear medicine applications.
The company’s portfolio includes Class I and Class II devices, with products listed under the FDA’s 510(k) clearance pathway. Medasys, Inc. is based in the United States.
Catalogue
Digital Nuclear Imaging System Ref K875198
510(k) 510(k)Pinnacle Image Processing System Ref K902648
510(k) 510(k)
Frequently asked questions
How many devices does Medasys, Inc. have in the registry?
The registry currently lists 2 devices for Medasys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medasys, Inc.'s devices?
Among its 2 most recently registered devices, Medasys, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medasys, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medasys, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medasys, Inc. in the registry?
The most recently registered devices listed for Medasys, Inc. include DIGITAL NUCLEAR IMAGING SYSTEM and PINNACLE IMAGE PROCESSING SYSTEM.