Cleared Special

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

K042602 · Ge Medical Systems, LLC · Radiology device

Jan 2005

Decision

111d

Days

Class 2

Risk

K042602 is an FDA 510(k) clearance for the REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).

Submitted by Ge Medical Systems, LLC (Milwaukee, US). The FDA issued a Cleared decision on January 13, 2005, 111 days after receiving the submission on September 24, 2004.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K042602 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2004
Decision Date	January 13, 2005
Days to Decision	111 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF