Viatronix, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Viatronix, Inc. makes
Viatronix, Inc. develops 3D medical imaging systems for diagnostic visualization, including the V3D Explorer for general anatomical exploration, the V3D Colon for colorectal assessments, and the V3D Cardiac for cardiac imaging. The company also offers the V3D Vascular for vascular studies and the V3D Calcium Scoring for coronary artery calcium evaluation. Their Visualization System (VVS) serves as a platform for integrating these imaging solutions.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where Viatronix, Inc. is based.
Catalogue
Viatronix V3D Explorer Ref K022789
Regimes: 510(k) Registry: 510(k)Viatronix V3D Colon Ref K020658
Regimes: 510(k) Registry: 510(k)Viatronix Visualization System (Vvs) Ref K002780
Regimes: 510(k) Registry: 510(k)Viatronix V3D Vascular, Revision 1.0 Ref K033361
Regimes: 510(k) Registry: 510(k)Viatronic V3D Calcium Scoring Ref K013146
Regimes: 510(k) Registry: 510(k)Viatronix V3D Explorer, Revision 1.2 Ref K032483
Regimes: 510(k) Registry: 510(k)Viatronix V3D Colon, Revision 1.3 Ref K040126
Regimes: 510(k) Registry: 510(k)Viatronix V3D-Cardiac, Revision 1.0 Ref K083293
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Viatronix, Inc. have in the registry?
The registry currently lists 8 devices for Viatronix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Viatronix, Inc.'s devices?
Among its 8 most recently registered devices, Viatronix, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Viatronix, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Viatronix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Viatronix, Inc. in the registry?
The most recently registered devices listed for Viatronix, Inc. include VIATRONIX V3D EXPLORER, VIATRONIX V3D COLON, VIATRONIX VISUALIZATION SYSTEM (VVS) and VIATRONIX V3D VASCULAR, REVISION 1.0.