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Luneray +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140803

by Nucletron B.V.

Identifiers

510(k) Number
K140803 FDA 510(k)
FDA Product Code
JAQ FDA 510(k)
Models / Variants
Luneray FDA 510(k)
catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm R75 Mm FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5700 FDA 510(k)
Regulation Number
892.5700 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Luneray Catheter is a remote-controlled radionuclide applicator system designed for brachytherapy procedures. It features a 6 French catheter with a length of 50 cm, paired with interchangeable needles of varying lengths (30 mm, 47 mm, 45 mm, 57 mm, 60 mm, 67 mm, and 75 mm) to deliver precise radiation doses to targeted tissues. This device is classified as a Class II medical device under FDA regulations and is intended for use in radiology settings for controlled radiation therapy applications.

The system is supplied as a reusable medical device and is regulated under 21 CFR 892.5700. It is intended for use in a clinical environment, typically within a radiation oncology department, where it is employed for interstitial brachytherapy. The catheter and needles are designed to be compatible with remote-controlled applicator systems, ensuring accurate placement and dose delivery. Sterility and proper handling are critical, as the device is used in sterile procedures. The device holds an FDA 510(k) clearance with the K-number K140803.

Frequently asked questions

What is the Luneray Catheter designed for in brachytherapy procedures?

The Luneray Catheter is a remote-controlled radionuclide applicator specifically designed for interstitial brachytherapy. It delivers precise radiation doses to targeted tissues by allowing controlled placement of radioactive sources through a 6 French catheter and interchangeable needles of varying lengths (30 mm to 75 mm). This design ensures accurate dose delivery in radiology settings, particularly within radiation oncology departments.

How is the Luneray Catheter supplied, and is it reusable?

The Luneray Catheter is supplied as a reusable medical device. It is intended for clinical use in sterile procedures, meaning proper sterilization and handling protocols must be followed before and after each use. Its reusable nature aligns with regulatory requirements under 21 CFR 892.5700, ensuring compliance for repeated applications in controlled environments.

What needle lengths are available for the Luneray Catheter, and how do they differ?

The Luneray Catheter system includes interchangeable needles with the following lengths: 30 mm, 47 mm, 45 mm, 57 mm, 60 mm, 67 mm, and 75 mm. These varying lengths allow clinicians to select the appropriate needle depth for specific treatment sites, ensuring optimal placement and dose distribution during brachytherapy procedures. The choice depends on the anatomical target and clinical requirements.

Is the Luneray Catheter sterile, and how should it be stored?

Sterility is critical for the Luneray Catheter, as it is used in sterile procedures. While the device itself is reusable, it must undergo proper sterilization between uses to maintain safety and efficacy. Storage should follow manufacturer guidelines to preserve sterility and functionality, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always refer to the provided instructions for specific storage recommendations.

What regulatory clearance does the Luneray Catheter hold, and how was it classified?

The Luneray Catheter holds FDA 510(k) clearance with the K-number K140803, demonstrating it is classified as substantially equivalent to a predicate device. It is categorized as a Class II medical device under FDA regulations, indicating it poses moderate risk and requires special controls to ensure safety and performance. The clearance was granted after review by the Radiology Advisory Committee (RA).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Luneray;Catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm ..., Luneray;Catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm ..., Luneray;Catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm ..., Luneray;catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nucletron B.V.

Sources (1)

  • FDA 510(k) K140803 24 fields · synced Oct 6, 2026