DIGITAL DIAGNOSTIC X-RAY SYSTEM— 510(k) K102408

Substantially Equivalent

DRGEM Corporation

FDA 510(k) clearance K102408 for DIGITAL DIAGNOSTIC X-RAY SYSTEM, Substantially Equivalent on 2010-12-27. Applicant: DRGEM Corporation.

Clearance details

Applicant: DRGEM Corporation
Product code: Code KPR
Advisory panel: Radiology
Date received: 2010-08-23
Decision date: 2010-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Echo, OR, 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.