FDA 510(k) Application Details - K955185

Device Classification Name System, Image Processing, Radiological

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510(K) Number K955185
Device Name System, Image Processing, Radiological
Applicant GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact ALLEN SCHUH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/13/1995
Decision Date 01/03/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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