FDA 510(k) Application Details - K033912

Device Classification Name System, Image Processing, Radiological

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510(K) Number K033912
Device Name System, Image Processing, Radiological
Applicant CRADLE TECHNOLOGY CORP.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 300 TW
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Contact JEN KE-MIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/17/2003
Decision Date 05/11/2004
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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