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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 K100552
Device Name RAYSTATION VERSION 1.0
Applicant
RAYSEARCH LABORATORIES AB
SVEAVAGEN 25, PLAN 9
STOCKHOLM,  SE SE-111 34
Applicant Contact ANDERS MURMAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received02/26/2010
Decision Date 03/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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