# K092550: Tigrt Ivs

- Pathway: 510(k) (Traditional)
- Applicant: Linatech, LLC
- Decided: Dec 15, 2009 after 118 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 K003285 (2001). 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)
- K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem, Brainlab AG (2007) Summary page 1.

## Indications for use
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.

Source page: https://510kreport.com/device/K092550
Methodology: https://510kreport.com/methodology