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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 K912573
Device Name VISION (NUCLEAR MEDICINE COMPUTER)
Applicant
Summit Nuclear
1993 Case Pkwy.
Twinsburg,  OH  44087
Applicant Contact GARY W ENOS
Correspondent
Summit Nuclear
1993 Case Pkwy.
Twinsburg,  OH  44087
Correspondent Contact GARY W ENOS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/11/1991
Decision Date 10/28/1991
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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