510(k) K251484

CT:VQ by 4Dmedical Limited — Product Code JAK

K251484 is an FDA 510(k) premarket notification submitted by 4Dmedical Limited for the device "CT:VQ". The FDA issued a decision of Substantially Equivalent on Aug 28, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. 4Dmedical Limited has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 28, 2025
Date Received
May 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type