Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fonar Corp. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
212 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061930 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY | Fonar Corp. | 2006-07-28 | 21 | 0 |
| K011485 | PINNACLE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 2001-06-06 | 22 | 0 |
| K003453 | SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS | Fonar Corp. | 2001-01-18 | 72 | 0 |
| K002490 | INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 2000-10-03 | 50 | 0 |
| K994287 | FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 2000-03-16 | 87 | 0 |
| K951681 | QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 1995-11-09 | 212 | 0 |
| K940772 | ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER) | Fonar Corp. | 1995-04-10 | 412 | 0 |
| K920789 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 1992-06-25 | 125 | 0 |
| K915567 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY) | Fonar Corp. | 1992-05-15 | 155 | 0 |
| K910839 | ULTIMATE 3000 | Fonar Corp. | 1991-07-26 | 149 | 0 |
| K883699 | B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | 1988-10-31 | 62 | 0 |
| K883648 | BETA 3000M MOBILE NMR IMAGING SYSTEM | Fonar Corp. | 1988-10-19 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda