# K171049: Real Time Image Gating System for Proton Beam Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd. Healthcare
- Decided: Dec 26, 2017 after 263 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: 9 generations back to K926449 (1995). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle, Medcom GmbH (2014) Summary page 4.
- K131965: XVI R5.0, Elekta Limited (2013) Summary page 4.

## Indications for use
The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

Source page: https://510kreport.com/device/K171049
Methodology: https://510kreport.com/methodology