LumenCare Azure
FDA 510(k) K262383 · Nucletron B.V.
510(k) numberK262383
Submission
- Device name
- LumenCare Azure
- Applicant
- Nucletron B.V.
Veenendaal, NL - Received
- July 13, 2026
- Decision date
- July 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | Varian Medical Systems | 05/20/2026SE |
| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
| K250299 | CT/ MR Tandem and Ovoid SetJAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2025SE |
| K250289 | Intracavitary/Interstitial SystemJAQ · Traditional | Varian Medical Systems | 04/25/2025SE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional | Varian Medical Systems, Inc. | 03/03/2025SE |
| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveJAQ · Traditional | Varian Medical Systems, Inc. | 11/07/2024SE |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251037 | Rectal ApplicatorJAQ · Traditional | 12/19/2025SE |
| K213942 | EsteyaJAD · Traditional | 01/11/2022SE |
| K201272 | GenevaJAQ · Traditional | 07/16/2020SE |
| K161688 | Advanced Gynecological ApplicatorJAQ · Traditional | 01/27/2017SE |
| K151272 | Henschke Titanium Applicator SetJAQ · Traditional | 06/23/2015SE |
| K142439 | Martinez Prostate Template SetJAQ · Traditional | 03/10/2015SE |
| K140803 | Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMJAQ · Traditional | 06/26/2014SE |
| K132816 | Oncentra BrachyMUJ · Traditional | 06/13/2014SE |
| K132889 | Fletcher Ct/Mr Shielded Applicator Set (6 MM) Fletcher Ct/Mr Shielded Applicator Set (4…JAQ · Traditional | 02/26/2014SE |
| K132874 | Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure Set 5F…JAQ · Special | 02/21/2014SE |
Questions and answers
When was LumenCare Azure cleared by the FDA?
LumenCare Azure (K262383) received a 510(k) decision of Substantially Equivalent on July 24, 2026, 11 days after the submission was received.
What is the product code of K262383?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.