FDA 510(k) Application Details - K994270

Device Classification Name System, Image Processing, Radiological

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510(K) Number K994270
Device Name System, Image Processing, Radiological
Applicant VISUALIZATION TECHNOLOGY, INC.
200 RESEARCH DR.
WILMINGTON, MA 01887 US
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Contact NORMA LEMAY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/20/1999
Decision Date 03/09/2000
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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