Accutome, Inc. Doing Business AS Keeler USA
Country not established
- Devices
- 1
What Accutome, Inc. Doing Business AS Keeler USA makes
Accutome, Inc. (Keeler USA) manufactures B-Scan ultrasound imaging systems, which are used for ophthalmic diagnostics to visualize the internal structures of the eye, including the retina and optic nerve.
The B-Scan system falls under FDA Class II regulation and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
B-Scan Ref K243227
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accutome, Inc. Doing Business AS Keeler USA have in the registry?
The registry currently lists 1 device for Accutome, Inc. Doing Business AS Keeler USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accutome, Inc. Doing Business AS Keeler USA's devices?
Among its 1 most recently registered device, Accutome, Inc. Doing Business AS Keeler USA has devices listed in FDA 510(k) (1 device).
What risk classes do Accutome, Inc. Doing Business AS Keeler USA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Accutome, Inc. Doing Business AS Keeler USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accutome, Inc. Doing Business AS Keeler USA in the registry?
The most recently registered devices listed for Accutome, Inc. Doing Business AS Keeler USA include B-Scan.