Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Norland Medical Systems, 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) |
|---|---|---|---|---|---|
| K993176 | MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY | Norland Medical Systems, Inc. | 2000-06-20 | 272 | 0 |
| K993337 | APOLLO MULTI-RACIAL REFERENCE POPULATION | Norland Medical Systems, Inc. | 2000-05-16 | 224 | 0 |
| K992125 | XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 | Norland Medical Systems, Inc. | 1999-11-22 | 152 | 1 |
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