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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 K904050
Device Name MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
Applicant
Philips Medical Systems (Cleveland), Inc.
23060 Miles Rd.
Cleveland,  OH  44128
Applicant Contact EDWARD KROLL
Correspondent
Philips Medical Systems (Cleveland), Inc.
23060 Miles Rd.
Cleveland,  OH  44128
Correspondent Contact EDWARD KROLL
Regulation Number892.1100
Classification Product Code
IYX  
Date Received09/04/1990
Decision Date 12/05/1990
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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