FDA applicant

Radiadyne

Houston, TX5 decisions2009–20170 recalls

FDA records 5 decisions for Radiadyne (Houston, TX) from 2009 to 2017: 4 510(k) clearances and 1 De Novo grant. Most are in product codes NZT (Dosimeter, Ionizing Radiation, Implanted) and JAQ (System, Applicator, Radionuclide…). Its devices cite 7 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Radiadyne, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Radiadyne’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009high 2 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Radiadyne by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radiadyne’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Radiadyne”

FDA records each applicant name separately; these may or may not be the same firm.

Radiadyne, LLC (Specification Developer) 1

Radiadyne

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Radiadyne”