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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 K882312
Device Name MODEL 3000 NUCLEAR CAMERA
Applicant
Ohio Imaging, Inc.
23060 Miles Rd.
Cleveland,  OH  44128
Applicant Contact EDWARD A KROLL
Correspondent
Ohio Imaging, Inc.
23060 Miles Rd.
Cleveland,  OH  44128
Correspondent Contact EDWARD A KROLL
Regulation Number892.1100
Classification Product Code
IYX  
Date Received06/03/1988
Decision Date 07/14/1988
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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