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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Orthovoltage, Therapeutic X-Ray
510(k) Number K914821
Device Name CRS RADIATION BEAM SCANNER
Applicant
Consolidated Radiation Services, Inc.
140 Sopwith Dr.
Vero Beach,  FL  32968
Applicant Contact BO ANDERSSON
Correspondent
Consolidated Radiation Services, Inc.
140 Sopwith Dr.
Vero Beach,  FL  32968
Correspondent Contact BO ANDERSSON
Regulation Number892.5900
Classification Product Code
IYI  
Date Received10/25/1991
Decision Date 12/17/1992
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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