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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 K875198
Device Name DIGITAL NUCLEAR IMAGING SYSTEM
Applicant
Medasys, Inc.
4651 Platt Rd.
Ann Arbor,  MI  48108
Applicant Contact FFRED MATZINGER
Correspondent
Medasys, Inc.
4651 Platt Rd.
Ann Arbor,  MI  48108
Correspondent Contact FFRED MATZINGER
Regulation Number892.1100
Classification Product Code
IYX  
Date Received12/17/1987
Decision Date 07/01/1988
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
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