DRX-Evolution with Carestream Digital Tomosynthesis— 510(k) K191879

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K191879 for DRX-Evolution with Carestream Digital Tomosynthesis, Substantially Equivalent on 2019-12-20. Applicant: Carestream Health, Inc..

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2019-07-15
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.