SYSTEM, X-RAY, STATIONARY— 510(k) K121854

Substantially Equivalent

Beijing Sinopharm Hundric Mediline Info. Tech. Co.

FDA 510(k) clearance K121854 for SYSTEM, X-RAY, STATIONARY, Substantially Equivalent on 2012-08-22. Applicant: Beijing Sinopharm Hundric Mediline Info. Tech. Co..

Clearance details

Applicant: Beijing Sinopharm Hundric Mediline Info. Tech. Co.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2012-06-25
Decision date: 2012-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.