Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Barcoview Mis Edinburgh · 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) |
|---|---|---|---|---|---|
| K070831 | VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION | Barcoview Mis Edinburgh | 2007-05-22 | 57 | 0 |
| K061326 | VOXAR 3D ENTERPRISE WITH CARDIAMETRIX | Barcoview Mis Edinburgh | 2006-05-25 | 15 | 0 |
| K060505 | VOXAR 3D ENTERPRISE, MODEL 6.1 | Barcoview Mis Edinburgh | 2006-03-29 | 30 | 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