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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K102615
Device Name WIRELESS DR IMAGING OPTION-WDR1
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JOHN L SCHMIDT
Correspondent
GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact JOHN L SCHMIDT
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/09/2010
Decision Date 11/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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