Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Imaging, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900062 | U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL | U.S. Imaging, Inc. | 1990-02-05 | 33 | 0 |
| K890878 | PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD | U.S. Imaging, Inc. | 1989-03-14 | 21 | 0 |
| K882358 | PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 | U.S. Imaging, Inc. | 1988-10-19 | 134 | 0 |
| K881886 | MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L | U.S. Imaging, Inc. | 1988-08-04 | 91 | 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