FDA 510(k) Application Details - K974504

Device Classification Name System, Image Processing, Radiological

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510(K) Number K974504
Device Name System, Image Processing, Radiological
Applicant E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
625 ALASKA AVE.
TORRANCE, CA 90503-5124 US
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Contact STU BUSH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/01/1997
Decision Date 02/27/1998
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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