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510(k) K050704

MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING by General Electric Co. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2005
Date Received
March 18, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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