REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING— 510(k) K042602

Name: FDA 510(k) clearance K042602
Creator: U.S. Food and Drug Administration
Published: 2005-01-13

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K042602 for REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING, Substantially Equivalent on 2005-01-13. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2004-09-24
Decision date: 2005-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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