IZF

System, X-Ray, Tomographic

Product code
IZF
Device name
System, X-Ray, Tomographic
Device class
Class 2
21 CFR
21 CFR 892.1740
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
4
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
42 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-02-02.

NumberDecision dateApplicantDevice nameSummary
K2526492026-02-02Nano-X Imaging , Ltd.TAP2DPDF
K2521332025-11-06Adaptix LimitedAdaptix Ortho350PDF
K2508502025-04-16Nano-X Imaging , Ltd.Nanox.ARC XPDF
K2423952024-12-04Nano-X Imaging , Ltd.Nanox.ARCPDF

4 summaries are archived here for direct download.

Official FDA classification page: IZF
Classification and pathway per current FDA publications. Data from openFDA (CC0).