Data / Medical devices / United States / Massachusetts General Hospital
Massachusetts General Hospital: FDA-registered device maker in Boston, MA, United States, 1 510(k) clearance
Massachusetts General Hospital is registered with the FDA (registration 3005374502) in Boston, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005374502
- FEI number
- 1270485
- Address
- 55 Fruit St, Boston, MA, United States, 02114
- Owner or operator
- Massachusetts General Hospital (10092759)
- Roles
- Manufacturer
- First device listed
- February 14, 2025
- Registered through
- 2027
- Brand names listed
- Gordon Browne Proton Therapy Center
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 |
|---|---|---|---|---|---|---|
| September 27, 2019 | K191521 | Radiance 330 Proton Beam Therapy System | LHN | Substantially Equivalent | Protom International Holding Corporation | accessdata.fda.gov |
Compare with other makers
Updated September 27, 2019. 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.