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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K102237
Device Name PVS MODEL 1.0
Applicant
Medcom GmbH
Rundeturmstr. 12
Darmstadt, Hessen,  DE 64283
Applicant Contact STEFAN WALTER
Correspondent
Medcom GmbH
Rundeturmstr. 12
Darmstadt, Hessen,  DE 64283
Correspondent Contact STEFAN WALTER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/09/2010
Decision Date 11/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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