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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 K896458
Device Name ASPECT GAMMA CAMERA
Applicant
Digital Scintigraphics, Inc.
1972 Massachusetts Ave. P.O.
Box 1012
Cambridge,  MA  02140
Applicant Contact GENNA, PHD
Correspondent
Digital Scintigraphics, Inc.
1972 Massachusetts Ave. P.O.
Box 1012
Cambridge,  MA  02140
Correspondent Contact GENNA, PHD
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/13/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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