Data / Medical devices / United States / Fonar Corp.
Fonar Corp.: FDA-registered device maker in Melville, NY, United States, 3 510(k) clearances
Fonar Corp. is registered with the FDA (registration 2432211) in Melville, NY, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 18, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2432211
- Address
- 110 Marcus Dr, Melville, NY, United States, 11747
- Owner or operator
- FONAR CORP. (2432211)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Indomitable, Quad 12000, Sympulse Computer System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 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 |
|---|---|---|---|---|---|---|
| January 18, 2001 | K003453 | SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS | LNH | Substantially Equivalent | Fonar Corp. | accessdata.fda.gov |
| October 3, 2000 | K002490 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER | LNH | Substantially Equivalent | Fonar Corp. | accessdata.fda.gov |
| November 9, 1995 | K951681 | QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER | LNH | Substantially Equivalent | Fonar Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 18, 2001. 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.