FDA 510(k) Application Details - K002911

Device Classification Name System, Image Processing, Radiological

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510(K) Number K002911
Device Name System, Image Processing, Radiological
Applicant RADIOGRAPHIC DIGITAL IMAGING, INC.
1215 SOUTH ALAMEDA ST.
COMPTON, CA 90220 US
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Contact STEPHEN NEUSHUL
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/18/2000
Decision Date 06/07/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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