# K070574: Flexitron

- Pathway: 510(k) (Abbreviated)
- Applicant: Isodose Control B.V.
- Decided: Apr 13, 2007 after 44 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912555 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 1.
- K031524: Gammamed Plus 3/24 HDR Remote Afterloader, Varian Medical Systems, Inc. (2003) Summary page 1.

## Recalls of this device
- Nov 18, 2019 · Class II · Z-0772-2020: A component failure may lead to treatment interruption or incorrect source positioning.

## Indications for use
The Flexitron Remotely Controlled Brachytherapy Afterloading System is intended to enable an operator to apply by remote control a radionuclide source (Flexisource) into the body or to the surface of the body for radiation therapy. Flexitron is intended to be used in combination with applicators which makes it suitable for intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy treatment. Flexitron is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and authorized medical professional.

Source page: https://510kreport.com/device/K070574
Methodology: https://510kreport.com/methodology