# K082530: Applicators for Afterloading Brachytherapy

- Pathway: 510(k) (Abbreviated)
- Applicant: Isodose Control B.V.
- Decided: Oct 30, 2008 after 58 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: 5 generations back to K864210 (1986). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE, Nucletron Corp. (1999) Summary page 2.
- K063382: HDR CT Compatible Split Ring Applicator, Mick Radio-Nuclear Instruments, Inc. (2006) Summary page 2.
- K011657: HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2001) Summary page 2.
- K060349: Proguide Needle Set, Nucletron Corporation (2006) Summary page 2.
- K073133: Interstitial Needles, Varian Medical Systems, Inc. (2007) Summary page 2.
- K003270: Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067, Nucletron Corp. (2000) Summary page 2.
- K990990: Cet Prostate Applicator Set, Part Number 089.066, Nucletron Corp. (1999) Summary page 2.
- K063815: Varian Esophagus Bougie Applicator, Varian Medical Systems (2007) Summary page 2.

## Indications for use
Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Cervix Ring Applicator The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation duration per treatment application is 28 days. Trocar Needle Sets The intended use is interstitial HDRIPDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days. Martinez Prostate Template Set The Martinez Prostate Template Set is for assisting interstitial HDRPPDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days. Bonvoisin Gerard Esophaqeal Applicator Set The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.

Source page: https://510kreport.com/device/K082530
Methodology: https://510kreport.com/methodology