VIATRONIX V3D-CARDIAC, REVISION 1.0— 510(k) K083293

Substantially Equivalent

Viatronix, Inc.

FDA 510(k) clearance K083293 for VIATRONIX V3D-CARDIAC, REVISION 1.0, Substantially Equivalent on 2008-12-05. Applicant: Viatronix, Inc..

Clearance details

Applicant: Viatronix, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2008-11-10
Decision date: 2008-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.