VISAGE PACS/CS, RELEASE VERSION 4.1— 510(k) K062490

Name: FDA 510(k) clearance K062490
Creator: U.S. Food and Drug Administration
Published: 2006-10-27

Substantially Equivalent

Mercury Computer Systems, Inc.

FDA 510(k) clearance K062490 for VISAGE PACS/CS, RELEASE VERSION 4.1, Substantially Equivalent on 2006-10-27. Applicant: Mercury Computer Systems, Inc.. Device class: 2.

Clearance details

Applicant: Mercury Computer Systems, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2006-08-25
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

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K072205 — VISAGE PACS/CS, RELEASE VERSION 5.02007-08-29

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.