# K080742: Verisuite 1.6, Verisuite-Particle 1.6

- Pathway: 510(k) (Traditional)
- Applicant: Medcom GmbH
- Decided: May 9, 2008 after 53 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: 5 generations back to K803130 (1981). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072506: Exactrac 5.5, Brainlab AG (2007) Summary page 1.
- K024147: Paxscan 4030 Medical Digital Imaging System, Varian Medical Systems, Inc. (2003) Summary page 2.
- K946320: R 302, Ralco S.R.L. (1995) Summary page 2.
- (no number) X-Ray Generator, Sedecal SHF 835: named in the summary without a submission number
- (no number) X-Ray Tubes, Varian A277 / A272: named in the summary without a submission number

## Most influential descendants
- K092653: Verisuite and Verisuite-Particle, Version 1.8 (2009), 3 descendants of its own
- K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle (2014), 2 descendants of its own
- 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
- K132847: I2C (2013), 0 descendants of its own

## Indications for use
The VeriSuite 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. It 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/K080742
Methodology: https://510kreport.com/methodology