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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 K251484
Device Name CT:VQ
Applicant
4DMedical Limited
Level 7/700 Swanston Street
Carlton,  AU 3053
Applicant Contact Theresa Poole
Correspondent
4DMedical Limited
Level 7/700 Swanston Street
Carlton,  AU 3053
Correspondent Contact Theresa Poole
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/14/2025
Decision Date 08/28/2025
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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