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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K141069
Device Name Lung Density Analysis
Applicant
IMBIO LLC
227 COLFAX AVE N
SUITE 144
MINNEAPOLIS,  MN  55405
Applicant Contact JASON SHEARD
Correspondent
IMBIO LLC
227 COLFAX AVE N
SUITE 144
MINNEAPOLIS,  MN  55405
Correspondent Contact JASON SHEARD
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/24/2014
Decision Date 09/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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