RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE— 510(k) K120344

Name: FDA 510(k) clearance K120344
Creator: U.S. Food and Drug Administration
Published: 2012-05-03

Substantially Equivalent

Radiadyne, LLC (Specification Developer)

FDA 510(k) clearance K120344 for RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE, Substantially Equivalent on 2012-05-03. Applicant: Radiadyne, LLC (Specification Developer). Device class: 2.

Clearance details

Applicant: Radiadyne, LLC (Specification Developer)
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2012-02-03
Decision date: 2012-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAQ

view all

K262383 — LumenCare Azure2026-07-24
K252717 — MAASTRO Rectal Applicator Set2026-05-20
K251037 — Rectal Applicator2025-12-19
K252884 — Guided Aarhus Applicator Set2025-11-19
K250299 — CT/ MR Tandem and Ovoid Set2025-05-09

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