Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viatronix, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
90 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083293 | VIATRONIX V3D-CARDIAC, REVISION 1.0 | Viatronix, Inc. | 2008-12-05 | 25 | 0 |
| K040126 | VIATRONIX V3D COLON, REVISION 1.3 | Viatronix, Inc. | 2004-04-19 | 90 | 0 |
| K033361 | VIATRONIX V3D VASCULAR, REVISION 1.0 | Viatronix, Inc. | 2003-11-05 | 15 | 0 |
| K032483 | VIATRONIX V3D EXPLORER, REVISION 1.2 | Viatronix, Inc. | 2003-08-22 | 10 | 0 |
| K022789 | VIATRONIX V3D EXPLORER | Viatronix, Inc. | 2002-09-06 | 15 | 0 |
| K020658 | VIATRONIX V3D COLON | Viatronix, Inc. | 2002-03-07 | 6 | 0 |
| K013146 | VIATRONIC V3D CALCIUM SCORING | Viatronix, Inc. | 2001-12-07 | 78 | 0 |
| K002780 | VIATRONIX VISUALIZATION SYSTEM (VVS) | Viatronix, Inc. | 2000-11-17 | 72 | 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