# K023519: Radionics Varilink 2

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, A Division of Tyco Healthcare Group LP
- Decided: Jan 16, 2003 after 87 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970586 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993594: Conformax MMLC VR1, Radionics, Inc. (1999) Summary page 1.

## Indications for use
The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The VariLink 2 MMLC can be used as a part of IMRT (Intensity Modulated Radiotherapy) or general conformal radiation treatment.

Source page: https://510kreport.com/device/K023519
Methodology: https://510kreport.com/methodology