FDA.report

510(k) K250766

Device
LungQ 4
Applicant
Thirona BV
510(k) number
K250766
Product code
JAK
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-02
Date received
2025-03-13
Regulation
892.1750
Classification name
System, X-Ray, Tomography, Computed
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Eva van Rikxoort
Address
Toernooiveld 300 Nijmegen NL 6525 EC 6525 EC

FDA Registration Numbers

Source Documents

510(k) summary PDF

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