# K955844: Applicators for Varian Varisource Remote High Dose Rate Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Jul 26, 1996 after 213 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: 1 generation back to K913908 (1992). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901615: Pulmocath Intrabronchial Catheter, Omnitron Intl., Inc. (1992) Summary page 1.
- K913908: Omnitron Gyn Applicator System, Omnitron Intl., Inc. (1992) Summary page 1.
- K952913: Applicators for Varian Varisource Remote High Soes Rate Afterloader, Varian Assoc., Inc. (1995) Summary page 1.

## Most influential descendants
- K063381: CT Compatible F/S/D Applicators (2006), 1 descendant of its own
- K200221: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (2020), 0 descendants of its own
- K172675: Varian Cervical Sleeves (2018), 0 descendants of its own
- K033828: CT Compatible Intrauterine Sleeves, Cat #0311, 9406 (2004), 0 descendants of its own

## Indications for use
The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to radiation during hand loading or hand placement of radioactive sources on or within the body of a patient. The radioactive source is iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatment. Between treatments the wire is retracted into the Afterloader and the source resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

Source page: https://510kreport.com/device/K955844
Methodology: https://510kreport.com/methodology