LumenCare Azure— 510(k) K262383

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.

Clearance details

Applicant: Nucletron B.V.
Product code: 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

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.

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.