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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 K952674
Device Name TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Applicant Contact KATHLEEN MURRAY
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent Contact KATHLEEN MURRAY
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/12/1995
Decision Date 09/26/1995
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
Recalls CDRH Recalls
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