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

Name: FDA 510(k) clearance K083293
Creator: U.S. Food and Drug Administration
Published: 2008-12-05

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.. Device class: 2.

Clearance details

Applicant: Viatronix, Inc.
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
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 ↗

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More clearances from Viatronix, Inc.

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K040126 — VIATRONIX V3D COLON, REVISION 1.32004-04-19
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K032483 — VIATRONIX V3D EXPLORER, REVISION 1.22003-08-22
K022789 — VIATRONIX V3D EXPLORER2002-09-06
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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.