Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
General Equipment For Medical Imaging (Oncovision- · 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) |
|---|---|---|---|---|---|
| K162052 | Sentinella 102, Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2016-08-18 | 24 | 0 |
| K143156 | Sentinella 102; Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2014-11-18 | 15 | 0 |
| K140996 | MAMMI | General Equipment For Medical Imaging (Oncovision- | 2014-06-11 | 55 | 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