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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 K945261
Device Name PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM
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 Received10/28/1994
Decision Date 03/21/1995
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
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