McLaren Health Care

FDA Device Registration & Listing · Flint, MI, US · Registration 3015178562

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015178562
FEI Number
3015178562
Entity Name
McLaren Health Care
City/State/Country
Flint, MI, US
Establishment Address
4100 Beecher Rd, Flint, MI 48532, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
McLaren Healthcare (Owner Number: 10089472)
Owner / Operator Contact Address
4100 Beecher Rd., Flint, MI 48532, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K160063
PMA Number
N/A

All Registered Proprietary Names

System, Radiation Therapy, Charged-Particle, Medical - McLaren Proton Therapy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2023-12-11

Official Correspondent

Kim Chaperon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

McLaren Healthcare
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2009 Intraop Medical Corporation 2
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015178562. Last updated year: 2026. Please use registration number 3015178562 when referencing this establishment in official correspondence.
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