Mclaren Health Care Corporation
Country not established
- Devices
- 8
What Mclaren Health Care Corporation makes
McLaren Health Care Corporation manufactures the McLaren Proton Therapy System, a radiation therapy device designed for precise cancer treatment using proton beams. This technology targets tumors with high accuracy while minimizing exposure to surrounding healthy tissue, making it suitable for complex cases requiring controlled radiation delivery.
The company’s proton therapy system is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The device operates within the United States, adhering to FDA compliance requirements for radiation therapy equipment.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
McLaren Proton Therapy System Ref K160063
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 791456056
- [email protected]
- Phone
- 810-342-3800
Frequently asked questions
How many devices does Mclaren Health Care Corporation have in the registry?
The registry currently lists 8 devices for Mclaren Health Care Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mclaren Health Care Corporation's devices?
Among its 8 most recently registered devices, Mclaren Health Care Corporation has devices listed in FDA 510(k) (1 device) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Mclaren Health Care Corporation's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Mclaren Health Care Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mclaren Health Care Corporation in the registry?
The most recently registered devices listed for Mclaren Health Care Corporation include McLaren Proton Therapy System ASSY-948, McLaren Range Shifter (15x15) (TR1) A001229, McLaren Range Shifter (30x30) (TR1) A001230 and McLaren Range Shifter (15x15) (TR2) A000906.