Real Time Image Gating System for Proton Beam Therapy Systems
510(k) K171049
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171049 | Date26 Dec 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LHN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Real Time Image Gating System for Proton Beam Therapy Systems is a radiation therapy device used with compatible Hitachi proton beam therapy systems. It generates gating signals to deliver a proton beam only when a fiducial marker implanted near a tumor is within a specified tolerance range. The system tracks the marker using X-ray fluoroscopy to manage motion during treatment.
This device is intended for use in clinical settings equipped with Hitachi proton therapy systems. It operates by synchronizing beam delivery with real-time imaging to target moving tumors while sparing surrounding healthy tissue. The system is supplied as part of an integrated proton therapy solution and is regulated under FDA 510(k) clearance with a traditional review pathway. It is a Class II medical device with product code LHN and is associated with multiple registration and FEI numbers.
Other devices from Hitachi, Ltd., Health Care Company
Questions
AI-generated answers, 22 Sep 2026
What is the Real Time Image Gating System used for?
It is used with Hitachi proton beam therapy systems to gate the radiation beam. The system monitors a fiducial marker implanted near a tumor using real-time X-ray fluoroscopy. When the marker moves outside a predefined tolerance range, the beam is paused, ensuring the proton dose is delivered only when the target is in the correct position, thereby sparing surrounding healthy tissue from unnecessary radiation exposure.
How does the system manage patient movement during treatment?
The system manages movement by continuously tracking a fiducial marker placed near the tumor using X-ray fluoroscopy. It generates gating signals in real time, synchronizing the proton beam delivery with the marker's position. If the marker deviates beyond a specified tolerance, the beam is automatically interrupted until the marker returns to the acceptable range, maintaining precise targeting despite respiratory or other physiological motion.
Is the system supplied as a standalone unit or integrated?
The system is supplied as part of an integrated proton therapy solution. It is designed to operate with compatible Hitachi proton beam therapy systems, functioning as a coordinated component that works in tandem with the main treatment delivery and imaging hardware to provide synchronized, real-time motion management during clinical procedures.
What regulatory pathway did this device follow for clearance?
The device was cleared under the FDA 510(k) premarket notification pathway. It was reviewed through the traditional review process and received a substantial equivalence (SESE) decision on December 26, 2017. As a Class II medical device with product code LHN, it is regulated under regulation number 892.5050 and was reviewed by the Radiology advisory committee.
What are the primary clinical applications of this technology?
The primary clinical application is the treatment of moving tumors, particularly those affected by patient respiration or other internal motion. By using real-time imaging to gate proton beam delivery, it allows for highly conformal dose distribution to the tumor while minimizing dose to adjacent critical structures, enhancing both treatment accuracy and patient safety in radiation oncology.