Data / Medical devices / United States / McLaren Health Care
McLaren Health Care: FDA-registered device maker in Flint, MI, United States, 1 510(k) clearance
McLaren Health Care is registered with the FDA (registration 3015178562) in Flint, MI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 25, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015178562
- Address
- 4100 Beecher Rd, Flint, MI, United States, 48532
- Owner or operator
- McLaren Healthcare (10089472)
- Roles
- Manufacturer
- First device listed
- December 11, 2023
- Registered through
- 2026
- Brand names listed
- System, Radiation Therapy, Charged-Particle, Medical - McLaren Proton Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2016 | K160063 | McLaren Proton Therapy System | LHN | Substantially Equivalent | Mclaren Health Care Corporation | accessdata.fda.gov |
Compare with other makers
Updated February 25, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.