Miles Inc., Agfa Division
United StatesFDA applicant, unverified
- Devices
- 2
What Miles Inc., Agfa Division makes
Miles Inc., Agfa Division manufactures digital identification cameras, including the DI-2000 model, designed for capturing and recording images of medical devices or patient identifiers. These devices are intended for use in clinical settings to ensure accurate labeling and traceability of equipment.
The company’s portfolio is classified under FDA’s Class I medical devices, requiring 510(k) clearance for market authorization. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Digital I.D. Camera Ref K942883
Regimes: 510(k) Registry: 510(k)Di-2000 Ref K943602
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Miles Inc., Agfa Division have in the registry?
The registry currently lists 2 devices for Miles Inc., Agfa Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Miles Inc., Agfa Division's devices?
Among its 2 most recently registered devices, Miles Inc., Agfa Division has devices listed in FDA 510(k) (2 devices).
What risk classes do Miles Inc., Agfa Division's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Miles Inc., Agfa Division's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Miles Inc., Agfa Division in the registry?
The most recently registered devices listed for Miles Inc., Agfa Division include DIGITAL I.D. CAMERA and DI-2000.