# K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle

- Pathway: 510(k) (Abbreviated)
- Applicant: Medcom GmbH
- Decided: Apr 3, 2014 after 101 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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: 7 generations back to K803130 (1981). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092653: Verisuite and Verisuite-Particle, Version 1.8, Medcom GmbH (2009) Summary page 1.
- K072506: Exactrac 5.5, Brainlab AG (2007) Summary page 2.

## Most influential descendants
- K181789: VeriSuite (2018), 0 descendants of its own
- K171049: Real Time Image Gating System for Proton Beam Therapy Systems (2017), 0 descendants of its own

## Indications for use
The YeniSuite patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. 1t is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.

Source page: https://510kreport.com/device/K133914
Methodology: https://510kreport.com/methodology