VIZION DR— 510(k) K102123

Name: FDA 510(k) clearance K102123
Creator: U.S. Food and Drug Administration
Published: 2011-01-24

Substantially Equivalent

Viztek, Inc.

FDA 510(k) clearance K102123 for VIZION DR, Substantially Equivalent on 2011-01-24. Applicant: Viztek, Inc.. Device class: 2.

Clearance details

Applicant: Viztek, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2010-07-29
Decision date: 2011-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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K091752 — VIZTEK WL2009-11-12
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K063337 — OPAL-RAD2006-12-12
K003607 — ONYX-RAD TELEMEDICINE PACS2001-02-15

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.