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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K933098
Device Name MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL
Applicant
Siemens Medical Solutions Health Services Corporat
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact SHERYL DYNER
Correspondent
Siemens Medical Solutions Health Services Corporat
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact SHERYL DYNER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received06/24/1993
Decision Date 09/20/1993
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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