DRX-REVOLUTION MOBILE X-RAY SYSTEM— 510(k) K120062

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K120062 for DRX-REVOLUTION MOBILE X-RAY SYSTEM, Substantially Equivalent on 2012-04-13. Applicant: Carestream Health, Inc..

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2012-01-09
Decision date: 2012-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.