FDA 510(k) Application Details - K132499

Device Classification Name System, Image Processing, Radiological

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510(K) Number K132499
Device Name System, Image Processing, Radiological
Applicant ICRCO INC.
2580 WEST 237TH STREET
TORRANCE, CA 90505 US
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Contact GREG WACHTLER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/09/2013
Decision Date 01/21/2014
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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