FDA 510(k) Application Details - K010271

Device Classification Name System, Image Processing, Radiological

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510(K) Number K010271
Device Name System, Image Processing, Radiological
Applicant THINKING SYSTEMS CORP.
6119 PRINCE DR.
SAN JOSE, CA 95129 US
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Contact J B WANG
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/29/2001
Decision Date 04/03/2001
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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