Fonar Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Fonar Corp.” (first 1988, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 12 | 12 |
Review panels
- Radiology (12)
Most recent Fonar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061930 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY | LNH | 2006-07-28 | 21 |
| K011485 | PINNACLE MAGNETIC RESONANCE IMAGING SCANNER | LNH | 2001-06-06 | 22 |
| K003453 | SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS | LNH | 2001-01-18 | 72 |
| K002490 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER | LNH | 2000-10-03 | 50 |
| K994287 | FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER | LNH | 2000-03-16 | 87 |
| K951681 | QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER | LNH | 1995-11-09 | 212 |
| K940772 | ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER) | LNH | 1995-04-10 | 412 |
| K920789 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | LNH | 1992-06-25 | 125 |
| K915567 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY) | LNH | 1992-05-15 | 155 |
| K910839 | ULTIMATE 3000 | LNH | 1991-07-26 | 149 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fonar Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Fonar Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fonar Corp.?
FDA lists 12 510(k) clearances under the applicant name “Fonar Corp.” (first 1988, latest 2006), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fonar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fonar Corp. is 80 days.
Which FDA product codes appear under Fonar Corp.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 12).
Next steps
- See all 12 Fonar Corp. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Fonar Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.