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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 K252041
Device Name Fibresolve (with PCCP)
Applicant
Imvaria, Inc.
2930 Domingo Ave. #1496
Berkeley,  CA  94705
Applicant Contact Joshua Reicher
Correspondent
RQM+
2790 Mosside Blvd.
Pittsburgh,  PA  15146
Correspondent Contact Dulciana Chan
Classification Product Code
QWO  
Date Received06/30/2025
Decision Date 11/07/2025
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		 Yes
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