KXK

Source, Brachytherapy, Radionuclide

Product code
KXK
Device name
Source, Brachytherapy, Radionuclide
Device class
Class 2
21 CFR
21 CFR 892.5730
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
151 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-12-05.

NumberDecision dateApplicantDevice nameSummary
K2522962025-12-05Oncopatch, Inc.OncoPatchPDF
K2428182025-07-15Isoaid, LLCIsoSpherePDF

2 summaries are archived here for direct download.

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