Ndi Medical, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Ndi Medical, LLC makes
Ndi Medical, LLC manufactures medical devices designed for radiation therapy verification, including the Checkpoint system with AccuStim technology and its variants for head and neck applications. These devices are used to confirm the accuracy of radiation delivery during treatment planning and delivery processes.
The company’s portfolio consists of Class II devices, which are regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) database and are based in the United States.
Catalogue
Checkpoint With Accustim Technology Ref K061365
Regimes: 510(k) Registry: 510(k)Checkpoint Ref K092292
Regimes: 510(k) Registry: 510(k)Checkpoint, Checkpoint Head & Neck Ref K150005
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ndi Medical, LLC have in the registry?
The registry currently lists 3 devices for Ndi Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ndi Medical, LLC's devices?
Among its 3 most recently registered devices, Ndi Medical, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Ndi Medical, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ndi Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ndi Medical, LLC in the registry?
The most recently registered devices listed for Ndi Medical, LLC include CHECKPOINT WITH ACCUSTIM TECHNOLOGY, CHECKPOINT and Checkpoint, Checkpoint Head & Neck.