Efilm Medical, Inc.
CanadaFDA applicant, unverified
- Devices
- 3
What Efilm Medical, Inc. makes
Efilm Medical, Inc. manufactures medical imaging workstations, including standalone EFILM Workstations and versions with modular add-ons, as well as EFILM Video systems designed for digital video capture and playback in clinical settings.
The company’s products are classified as Class II devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Efilm Workstation With Modules Ref K020995
Regimes: 510(k) Registry: 510(k)Efilm Workstation Ref K012211
Regimes: 510(k) Registry: 510(k)Efilm Video Ref K013631
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Efilm Medical, Inc. have in the registry?
The registry currently lists 3 devices for Efilm Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Efilm Medical, Inc.'s devices?
Among its 3 most recently registered devices, Efilm Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Efilm Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Efilm Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Efilm Medical, Inc. in the registry?
The most recently registered devices listed for Efilm Medical, Inc. include EFILM WORKSTATION WITH MODULES, EFILM WORKSTATION and EFILM VIDEO.