# K090802: Tigrt MLC, Tigrt DMLC

- Pathway: 510(k) (Traditional)
- Applicant: Linatech, LLC
- Decided: Jul 7, 2009 after 105 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 K004022 (2002). 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)
- K060187: Topslane DMLC, Topslane International, LLC (2006) Summary page 1.

## Indications for use
TIGRT MLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Source page: https://510kreport.com/device/K090802
Methodology: https://510kreport.com/methodology