REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS— 510(k) K051967

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K051967 for REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS, Substantially Equivalent on 2005-08-09. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code KPR
Advisory panel: Radiology
Date received: 2005-07-20
Decision date: 2005-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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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.