Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ohio Nuclear, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
41 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K792603 | COMPUTED TOMOGRAPHY X-RAY SCANNER | Ohio Nuclear, Inc. | 1980-01-28 | 41 | 0 |
| K791195 | DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN | Ohio Nuclear, Inc. | 1979-07-30 | 34 | 0 |
| K781079 | SONOGRAF ULTRASOUND B-SCANNING SYSTEM | Ohio Nuclear, Inc. | 1978-07-17 | 19 | 0 |
| K780165 | PROCESSOR, VIDEO IMAGE VIP-550 | Ohio Nuclear, Inc. | 1978-03-02 | 30 | 0 |
| K780115 | SCANNERS, TOMOGRAPHIC, COMPUTED | Ohio Nuclear, Inc. | 1978-01-30 | 11 | 0 |
| K772305 | RAD. THERAPY PLANNING SUP. SYS. | Ohio Nuclear, Inc. | 1978-01-09 | 26 | 0 |
| K771082 | DELTASCAN 2000 SERIES | Ohio Nuclear, Inc. | 1977-06-24 | 9 | 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