VIATRONIX V3D COLON, REVISION 1.3— 510(k) K040126

Name: FDA 510(k) clearance K040126
Creator: U.S. Food and Drug Administration
Published: 2004-04-19

Substantially Equivalent

Viatronix, Inc.

FDA 510(k) clearance K040126 for VIATRONIX V3D COLON, REVISION 1.3, Substantially Equivalent on 2004-04-19. Applicant: Viatronix, Inc.. Device class: 2.

Clearance details

Applicant: Viatronix, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-01-20
Decision date: 2004-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Viatronix, Inc.

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K083293 — VIATRONIX V3D-CARDIAC, REVISION 1.02008-12-05
K033361 — VIATRONIX V3D VASCULAR, REVISION 1.02003-11-05
K032483 — VIATRONIX V3D EXPLORER, REVISION 1.22003-08-22
K022789 — VIATRONIX V3D EXPLORER2002-09-06
K020658 — VIATRONIX V3D COLON2002-03-07

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.