# K945383: High Dose Rate Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Feb 15, 1995 after 113 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
No predicates in its family tree.
27 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992577: Photon Radiosurgery System (PRS) (1999), 20 descendants of its own
- K051055: Intrabeam System (2005), 9 descendants of its own
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own
- K061582: Varisource 200 HDR Afterloader (2006), 8 descendants of its own
- K050843: Axxent Electronic Brachytherapy System (2005), 8 descendants of its own

Source page: https://510kreport.com/device/K945383
Methodology: https://510kreport.com/methodology