Onlume, Inc.
Country not established
- Devices
- 1
What Onlume, Inc. makes
Onlume, Inc. manufactures the Asimov-MKS Imaging System, a medical imaging device designed for specific diagnostic applications in radiology.
The Asimov-MKS Imaging System is classified as a Class II device under FDA regulations and is listed in the 510(k) clearance registry. The company is based in the United States.
Catalogue
Asimov-MKS Imaging System Ref K192761
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Onlume, Inc. have in the registry?
The registry currently lists 1 device for Onlume, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Onlume, Inc.'s devices?
Among its 1 most recently registered device, Onlume, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Onlume, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Onlume, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Onlume, Inc. in the registry?
The most recently registered devices listed for Onlume, Inc. include Asimov-MKS Imaging System.