RadianceTx Radionuclide Brachytherapy Source— 510(k) K223465

Substantially Equivalent

Radiance Therapeutics, Inc.

FDA 510(k) clearance K223465 for RadianceTx Radionuclide Brachytherapy Source, Substantially Equivalent on 2023-01-11. Applicant: Radiance Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant
Radiance Therapeutics, Inc.
Product code
Code KXK
Device class
Class 2
Regulation
21 CFR 892.5730
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tucson, AZ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KXK

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.