ONYX-RAD TELEMEDICINE PACS— 510(k) K003607

Name: FDA 510(k) clearance K003607
Creator: U.S. Food and Drug Administration
Published: 2001-02-15

Substantially Equivalent

Viztek, Inc.

FDA 510(k) clearance K003607 for ONYX-RAD TELEMEDICINE PACS, Substantially Equivalent on 2001-02-15. Applicant: Viztek, Inc.. Device class: 2.

Clearance details

Applicant: Viztek, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2000-11-22
Decision date: 2001-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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K102123 — VIZION DR2011-01-24
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K082604 — VIZTEK DR, MODELS: DR1000, DR3000, DR40002008-11-21
K063337 — OPAL-RAD2006-12-12

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.