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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name couch, radiation therapy, powered
510(k) Number K122413
Device Name PATIENT POSITIONING SYSTEM
Original Applicant
FORTE AUTOMATION SYSTEMS, INC.
8155 burden rd
machesney park,  IL  61115
Original Contact phil reece
Regulation Number892.5770
Classification Product Code
JAI  
Date Received08/08/2012
Decision Date 09/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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