Stabilix, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Stabilix, LLC makes
Stabilix, LLC manufactures the AerFrame Patient Immobilization System, a device designed to securely position and immobilize patients during medical imaging procedures, ensuring stability and reducing motion artifacts.
The AerFrame Patient Immobilization System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
AerFrame™ Alignment Laser Box (LBV2) Ref K261865
Regimes: 510(k) Registry: 510(k)AerFrame Patient Immobilization System (AFPIS) Ref K260792
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stabilix, LLC have in the registry?
The registry currently lists 2 devices for Stabilix, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stabilix, LLC's devices?
Among its 2 most recently registered devices, Stabilix, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Stabilix, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stabilix, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stabilix, LLC in the registry?
The most recently registered devices listed for Stabilix, LLC include AerFrame™ Alignment Laser Box (LBV2) and AerFrame Patient Immobilization System (AFPIS).