Elucid Bioimaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Elucid Bioimaging, Inc. makes
Elucid Bioimaging, Inc. manufactures intravascular imaging devices, including the vascuCAP for coronary artery visualization and the Elucid PlaqueIQ for plaque characterization. The ElucidVivo A.3 is an intravascular imaging system designed for real-time coronary artery assessment.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is headquartered in the United States.
Catalogue
- Registry: GUDID
Elucid FFR-IQ (B.1) Ref K262015
Regimes: 510(k) Registry: 510(k)Elucid PlaqueIQ Ref K261855
Regimes: 510(k) Registry: 510(k)- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
vascuCAP Ref K183012
Regimes: 510(k) Registry: 510(k)vascuCAP Ref K163071
Regimes: 510(k) Registry: 510(k)Elucid PlaqueIQ Ref K241524
Regimes: 510(k) Registry: 510(k)ElucidVivo A.3 Ref K221463
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 079267473
- [email protected]
- Phone
- +1(617)304-9520
Frequently asked questions
How many devices does Elucid Bioimaging, Inc. have in the registry?
The registry currently lists 10 devices for Elucid Bioimaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elucid Bioimaging, Inc.'s devices?
Among its 10 most recently registered devices, Elucid Bioimaging, Inc. has devices listed in FDA 510(k) (6 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Elucid Bioimaging, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Elucid Bioimaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elucid Bioimaging, Inc. in the registry?
The most recently registered devices listed for Elucid Bioimaging, Inc. include ElucidPlaqueIQ B.1P, Elucid FFR-IQ (B.1), Elucid PlaqueIQ and vascuCAP A.1.2.