Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Strichman Medical Equipment, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925186 | EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS | Strichman Medical Equipment, Inc. | 1993-01-12 | 90 | 0 |
| K923736 | GAMMA 600T | Strichman Medical Equipment, Inc. | 1992-10-16 | 81 | 0 |
| K903469 | GAMMA 600 NUCLEAR MEDICINE COMPUTER | Strichman Medical Equipment, Inc. | 1991-02-04 | 187 | 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