CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION— 510(k) K132824

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K132824 for CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION, Substantially Equivalent on 2014-02-06. Applicant: Carestream Health, Inc..

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-09-09
Decision date: 2014-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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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.