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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 K241891
Device Name ScreenDx
Applicant
Imvaria, Inc
2930 Domingo Ave #1496
Berkeley,  CA  94705
Applicant Contact Joshua Reicher
Correspondent
RQM+
2790 Mosside Blvd
Monroeville,  PA  15146
Correspondent Contact Dulciana Chan
Classification Product Code
QWO  
Date Received06/28/2024
Decision Date 01/10/2025
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		 No
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