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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 K922426
Device Name SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM
Applicant
Summit Nuclear
1993 Case Pkwy.
Twinsburg,  OH  44087
Applicant Contact JOCHEN ROGERS
Correspondent
Summit Nuclear
1993 Case Pkwy.
Twinsburg,  OH  44087
Correspondent Contact JOCHEN ROGERS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/22/1992
Decision Date 09/28/1992
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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