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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 K100056
Device Name MEDCOM RT-VIEWER SYSTEM
Applicant
MEDCOM GMBH
12 RUNDETURMSTRASSE
DARMSTADT, HESSEN,  DE 64283
Applicant Contact STEFAN WALTER
Correspondent
MEDCOM GMBH
12 RUNDETURMSTRASSE
DARMSTADT, HESSEN,  DE 64283
Correspondent Contact STEFAN WALTER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/08/2010
Decision Date 05/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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