LumenCare Azure— 510(k) K262383

Name: FDA 510(k) clearance K262383
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

Nucletron B.V.

FDA 510(k) clearance K262383 for LumenCare Azure, Substantially Equivalent on 2026-07-24. Applicant: Nucletron B.V.. Device class: 2.

Summary

LumenCare Azure from Nucletron is filed under JAQ, remote-controlled radionuclide applicator systems. The record doesn't describe the product's components.

Class II, 21 CFR 892.5700. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).

Nucletron filed from Veenendaal, Netherlands. The decision came 11 calendar days after receipt (July 13 to July 24, 2026).

Clearance details

Applicant: Nucletron B.V.
Product code: Product code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2026-07-13
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAQ

view all

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
K250289 — Intracavitary/Interstitial System2025-04-25

More clearances from Nucletron B.V.

view all

K213942 — Esteya2022-01-11
K201272 — Geneva2020-07-16
K161688 — Advanced Gynecological Applicator2017-01-27
K151272 — Henschke Titanium Applicator Set2015-06-23
K142439 — Martinez Prostate Template Set2015-03-10

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