FDA 510(k) Application Details - K965179

Device Classification Name System, Image Processing, Radiological

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510(K) Number K965179
Device Name System, Image Processing, Radiological
Applicant NEO IMAGERY TECHNOLOGIES, INC.
2315 S. BIRCH LOG WAY
HACIENDA HEIGHTS, CA 91745 US
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Contact TINA YOUNG
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/24/1996
Decision Date 07/03/1997
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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