FDA 510(k) Application Details - K182419

Device Classification Name System, Image Processing, Radiological

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510(K) Number K182419
Device Name System, Image Processing, Radiological
Applicant GE Healthcare
500 West Monroe Street
Chicago, IL 60661-3671 US
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Contact Renee Webb
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/05/2018
Decision Date 12/14/2018
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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