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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 K850397
Device Name ORBITOR II COUNTER BALANCE CAMERA
Applicant
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Applicant Contact JOSEPH P STOWELL
Correspondent
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Correspondent Contact JOSEPH P STOWELL
Regulation Number892.1100
Classification Product Code
IYX  
Date Received02/01/1985
Decision Date 03/26/1985
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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