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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
510(k) Number K242467
Device Name IQ-UIP
Applicant
Imbio, Inc.
1015 Glenwood Ave.
Floor 4
Minneapolis,  MN  55405
Applicant Contact William McLain
Correspondent
Imbio, Inc.
1015 Glenwood Ave.
Floor 4
Minneapolis,  MN  55405
Correspondent Contact William McLain
Classification Product Code
QWO  
Date Received08/20/2024
Decision Date 12/19/2024
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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