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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 K851644
Device Name SPECTRUM 150 DT
Applicant
Raytheon Medical Systems
2020 N.Janice Ave.
Melrose Park,  IL  60160
Applicant Contact JEFFREY N MOELLER
Correspondent
Raytheon Medical Systems
2020 N.Janice Ave.
Melrose Park,  IL  60160
Correspondent Contact JEFFREY N MOELLER
Regulation Number892.1100
Classification Product Code
IYX  
Date Received04/19/1985
Decision Date 05/21/1985
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
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