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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, multi format, radiological
510(k) Number K955394
Device Name SIENET TELERADIOLOGY PRODUCT LINE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
iselin,  NJ  08830
Applicant Contact amy s hosler
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
iselin,  NJ  08830
Correspondent Contact amy s hosler
Regulation Number892.2040
Classification Product Code
LMC  
Date Received11/24/1995
Decision Date 02/21/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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