FDA 510(k) Application Details - K974455

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K974455
Device Name System, X-Ray, Tomography, Computed
Applicant ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY, MA 01960 US
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Contact ROBERT H FRENCH
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 11/25/1997
Decision Date 02/20/1998
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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