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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K935273
Device Name VISION FX 40 & 80 SERIES GAMMA CAMERA
Applicant
Summit Nuclear
1993 Case Pkwy.
Twinsburg,  OH  44087
Applicant Contact ROBERT H MCCARTHY
Correspondent
Summit Nuclear
1993 Case Pkwy.
Twinsburg,  OH  44087
Correspondent Contact ROBERT H MCCARTHY
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/02/1993
Decision Date 04/18/1994
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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