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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K101279
Device Name CORRIDOR4DM V2010 MODEL: V2010
Applicant
Invia
200 Homer Ave.
Ashland,  MA  01721
Applicant Contact DAVID ROTHKOPF
Correspondent
Invia
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact DAVID ROTHKOPF
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
JAK   KPS  
Date Received05/06/2010
Decision Date 08/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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