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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 K110511
Device Name E4D COMPASS
Applicant
D4D Technologies
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Applicant Contact Allison Scott
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/23/2011
Decision Date 03/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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