# K181789: VeriSuite

- Pathway: 510(k) (Abbreviated)
- Applicant: Medcom GmbH
- Decided: Sep 21, 2018 after 78 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: 8 generations back to K803130 (1981). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 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 5.
- K122451: Exactrac Vero, Brainlab AG (2012) Summary page 5.
- K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle, Medcom GmbH (2014) Summary page 7.

## Indications for use
VeriSuite is an image processing software for verification of the patient position and calculation of a correction vector for the treatment of tumors during a radiation therapy with photons, electrons (from a linear accelerator) or particles (protons). An authorized person must evaluate the correctness of the calculation and approve the result for further usage. The system shall only be used after correct installation in appropriate treatment rooms by trained personnel. Legal regulations especially regulation for the operation of X-ray devices must be regarded. VeriSuite must not be used for diagnostic purposes.

Source page: https://510kreport.com/device/K181789
Methodology: https://510kreport.com/methodology