DRX - Compass— 510(k) K223842

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K223842 for DRX - Compass, Substantially Equivalent on 2023-01-20. Applicant: Carestream Health, Inc..

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2022-12-22
Decision date: 2023-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: China (Shanghai) Pilot Free Trade Zone, CN

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.