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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K962892
Device Name HELAX TMS BRACHYTHERAPY, VERSION 3.0
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Applicant Contact KENNETH R MICHAEL
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Correspondent Contact KENNETH R MICHAEL
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/24/1996
Decision Date 10/29/1996
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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