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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 K934722
Device Name PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION
Applicant
Ohio Imaging, Inc.
23060 Miles Rd.
Cleveland,  OH  44128
Applicant Contact NORMAN J YAGER
Correspondent
Ohio Imaging, Inc.
23060 Miles Rd.
Cleveland,  OH  44128
Correspondent Contact NORMAN J YAGER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/29/1993
Decision Date 05/13/1994
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
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