Imvaria, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Imvaria, Inc. makes
Imvaria, Inc. manufactures diagnostic devices for gastrointestinal assessment, including Fibresolve (with PCCP) for detecting esophageal conditions and ScreenDx for identifying precancerous lesions in the gastrointestinal tract.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. Imvaria, Inc. is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Fibresolve (with PCCP) Ref K252041
Regimes: 510(k) Registry: 510(k)ScreenDx Ref K241891
Regimes: 510(k) Registry: 510(k)Fibresolve Ref DEN220040
Regimes: De Novo Registry: De Novo
Company details
- DUNS number
- 117159593
Frequently asked questions
How many devices does Imvaria, Inc. have in the registry?
The registry currently lists 6 devices for Imvaria, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Imvaria, Inc.'s devices?
Among its 6 most recently registered devices, Imvaria, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Imvaria, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Imvaria, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Imvaria, Inc. in the registry?
The most recently registered devices listed for Imvaria, Inc. include Fibresolve 1.0, ScreenDx 1.0, Fibresolve 2.0 and Fibresolve (with PCCP).