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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
Predetermined Change
Control Plan Authorized		 No
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