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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K963162
Device Name QUANTEM
Applicant
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Applicant Contact THOMAS J SPACKMAN, M.D.,F.A.C.R.
Correspondent
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Correspondent Contact THOMAS J SPACKMAN, M.D.,F.A.C.R.
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/14/1996
Decision Date 11/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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