Epica International, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Epica International, Inc. makes
Epica International, Inc. manufactures the See Factor CT3™, a computed tomography (CT) imaging device designed for specific diagnostic applications in radiology. This device is intended for use in medical imaging to assess bone density and structural integrity, particularly in orthopedic and trauma evaluations.
The company’s portfolio is regulated under Class II medical devices in the United States, with individual products authorised through the FDA’s 510(k) clearance process. The See Factor CT3 is listed in the FDA’s 510(k) registry, reflecting its compliance with applicable regulatory requirements.
Catalogue
See Factor CT3™ Ref K233230
Regimes: 510(k) Registry: 510(k)SeeFactorCT3 Ref K190856
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Epica International, Inc. have in the registry?
The registry currently lists 2 devices for Epica International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epica International, Inc.'s devices?
Among its 2 most recently registered devices, Epica International, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Epica International, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Epica International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epica International, Inc. in the registry?
The most recently registered devices listed for Epica International, Inc. include See Factor CT3™ and SeeFactorCT3.