FDA 510(k) Application Details - K980970

Device Classification Name System, Image Processing, Radiological

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510(K) Number K980970
Device Name System, Image Processing, Radiological
Applicant STERLING DIAGNOSTIC IMAGING, INC.
10 SOUTH ACADEMY ST.
MAIL DROP 120
GREENVILLE, SC 29601 US
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Contact JEAN E BARTLETT
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/16/1998
Decision Date 06/08/1998
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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