Viatronix, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Viatronix, Inc.” (first 2000, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 20 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
Review panels
- Radiology (8)
Most recent Viatronix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083293 | VIATRONIX V3D-CARDIAC, REVISION 1.0 | JAK | 2008-12-05 | 25 |
| K040126 | VIATRONIX V3D COLON, REVISION 1.3 | LLZ | 2004-04-19 | 90 |
| K033361 | VIATRONIX V3D VASCULAR, REVISION 1.0 | LLZ | 2003-11-05 | 15 |
| K032483 | VIATRONIX V3D EXPLORER, REVISION 1.2 | LLZ | 2003-08-22 | 10 |
| K022789 | VIATRONIX V3D EXPLORER | LLZ | 2002-09-06 | 15 |
| K020658 | VIATRONIX V3D COLON | LLZ | 2002-03-07 | 6 |
| K013146 | VIATRONIC V3D CALCIUM SCORING | JAK | 2001-12-07 | 78 |
| K002780 | VIATRONIX VISUALIZATION SYSTEM (VVS) | LLZ | 2000-11-17 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Viatronix, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Viatronix, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Viatronix, Inc.” (first 2000, latest 2008), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Viatronix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viatronix, Inc. is 20 days.
Which FDA product codes appear under Viatronix, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6); JAK (System, X-Ray, Tomography, Computed, 2).
Next steps
- See all 8 Viatronix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Viatronix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.