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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K130617
Device Name RAYSTATION
Applicant
RAYSEARCH LABORATORIES AB
SVEAVAGEN 25, PLAN 9
STOCKHOLM,  SE SE-111 34
Applicant Contact DAVID HEDFORS
Correspondent
RAYSEARCH LABORATORIES AB
SVEAVAGEN 25, PLAN 9
STOCKHOLM,  SE SE-111 34
Correspondent Contact DAVID HEDFORS
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/07/2013
Decision Date 05/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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