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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K853395
Device Name RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000
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 Number892.1710
Classification Product Code
IZH  
Date Received08/12/1985
Decision Date 11/01/1985
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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