Breakaway Imaging, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Breakaway Imaging, LLC makes
Breakaway Imaging, LLC makes the O-ARM Imaging System, a medical imaging device used for intraoperative imaging in surgical settings.
The O-ARM Imaging System is classified as a Class II device and is listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
O-Arm Imaging System Ref K050996
510(k) 510(k)O-Arm Imaging System Ref K060344
510(k) 510(k)
Frequently asked questions
How many devices does Breakaway Imaging, LLC have in the registry?
The registry currently lists 2 devices for Breakaway Imaging, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breakaway Imaging, LLC's devices?
Among its 2 most recently registered devices, Breakaway Imaging, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Breakaway Imaging, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Breakaway Imaging, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Breakaway Imaging, LLC in the registry?
The most recently registered devices listed for Breakaway Imaging, LLC include O-ARM IMAGING SYSTEM.