FDA 510(k) Application Details - K964778

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K964778
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant HEALTH IMAGES, INC.
8601 DUNWOODY PLACE
SUITE 200
ATLANTA, GA 30350 US
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Contact RICHARD E HALBACH
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 11/27/1996
Decision Date 02/24/1997
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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