# K140803: Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Jun 26, 2014 after 87 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864210 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 2.
- K032372: Nucletron Comfort Catheter System, Model 189.007, Nucletron Corporation (2003) Summary page 2.

## Indications for use
Luneray is intended for interstitial brachytherapy of soft tissue that allows the Insertion of this flexible applicator, e.g.: Abdominal structures / organs (e.g. urinary bladder) Head and neck (e.g. ear, lip, nose, tongue, oral mucosa) Skin (e.g. keloids) Soft tissue sarcoma Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.

Source page: https://510kreport.com/device/K140803
Methodology: https://510kreport.com/methodology