IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO— 510(k) K022292

Name: FDA 510(k) clearance K022292
Creator: U.S. Food and Drug Administration
Published: 2002-09-12

Substantially Equivalent

Agfa Corp.

FDA 510(k) clearance K022292 for IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO, Substantially Equivalent on 2002-09-12. Applicant: Agfa Corp.. Device class: 2.

Clearance details

Applicant: Agfa Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2002-07-15
Decision date: 2002-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brevard, NC, US

Download summary PDF View on FDA.gov ↗

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K042779 — RADIOTHERAPY SOLUTION BASED ON CR2004-10-21

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.