FDA 510(k) Application Details - K051673

Device Classification Name System, Image Processing, Radiological

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510(K) Number K051673
Device Name System, Image Processing, Radiological
Applicant GE MEDICAL SYSTEMS
3000 N GRANDVIEW BLVD.
W-709
WAUKESHA, WI 53188 US
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Contact LARRY A KROGER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/23/2005
Decision Date 07/18/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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