ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE— 510(k) K955092

Name: FDA 510(k) clearance K955092
Creator: U.S. Food and Drug Administration
Published: 1996-05-09

Substantially Equivalent

Cemax-Icon, Inc.

FDA 510(k) clearance K955092 for ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE, Substantially Equivalent on 1996-05-09. Applicant: Cemax-Icon, Inc.. Device class: 2.

Clearance details

Applicant: Cemax-Icon, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1995-11-07
Decision date: 1996-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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Recent devices under product code LLZ

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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.