Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorad Medical Systems, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
265 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921962 | LORAD DIGITAL SPOT MAMMOGRAPHY | Lorad Medical Systems, Inc. | 1992-11-23 | 210 | 0 |
| K922619 | DIGITIZER, MODEL # 3-000A-1518 | Lorad Medical Systems, Inc. | 1992-07-01 | 33 | 0 |
| K913732 | MAMMOGRAPHIC X-RAY SYSTEM | Lorad Medical Systems, Inc. | 1992-02-03 | 167 | 0 |
| K913478 | RADIOGRAPHIC FILM MARKING SYSTEM | Lorad Medical Systems, Inc. | 1991-10-15 | 70 | 0 |
| K894935 | S-70 PORTABLE DENTAL X-RAY SYSTEM | Lorad Medical Systems, Inc. | 1990-04-25 | 265 | 0 |
| K894643 | RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT | Lorad Medical Systems, Inc. | 1989-12-14 | 143 | 0 |
| K882875 | STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY | Lorad Medical Systems, Inc. | 1988-11-07 | 119 | 0 |
| K842102 | LORAD | Lorad Medical Systems, Inc. | 1984-07-17 | 53 | 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