Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorad, A Hologic Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
116 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122836 | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | Lorad, A Hologic Co. | 2013-01-11 | 116 | 0 |
| K071542 | DIGITAL STEREOLOC II | Lorad, A Hologic Co. | 2007-07-05 | 30 | 0 |
| K030666 | MULTICARE PLATINUM SYSTEM AND ACCESSORIES | Lorad, A Hologic Co. | 2003-03-25 | 22 | 0 |
| K013290 | MODIFIED 650 MAMMOGRAPHY SYSTEM | Lorad, A Hologic Co. | 2001-10-24 | 22 | 0 |
| K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM | Lorad, A Hologic Co. | 2001-07-11 | 15 | 3 |
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