Irom Imaging, Inc.
Country not established
- Devices
- 1
What Irom Imaging, Inc. makes
Irom Imaging, Inc. manufactures the MXR-2000, a mobile X-ray unit designed for portable radiographic imaging in clinical and field settings. This device enables on-site imaging for patients who cannot be easily transported to a fixed radiology facility, supporting diagnostics in emergency, surgical, and outpatient environments.
The MXR-2000 is classified as a Class II medical device under FDA regulations and has been authorised through the 510(k) clearance process. The company is headquartered in the United States, where its products are listed for commercial distribution and use.
Catalogue
Mxr-2000 Mobile X-Ray Unit Ref K010304
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Irom Imaging, Inc. have in the registry?
The registry currently lists 1 device for Irom Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Irom Imaging, Inc.'s devices?
Among its 1 most recently registered device, Irom Imaging, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Irom Imaging, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Irom Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Irom Imaging, Inc. in the registry?
The most recently registered devices listed for Irom Imaging, Inc. include MXR-2000 MOBILE X-RAY UNIT.