FDA Device Intelligence
Home › EhmetDx LLC › X-ray Imaging System (XIS)

X-ray Imaging System (XIS)

EhmetDx LLC · Model v.1.x · UDI-DI 00866854000401

LHN Prescription
1
510(k) clearances
136
Adverse events (2 deaths)
58
Recalls
27
Facilities

Description

The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS. The software product integrates with the following components of the MPTS system: • X-ray generator & tube assembly • Amorphous silicon flat-panel detector • Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs. There are two defined methods of registration, 1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system. 2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis

Recalls

DateFirmReason
2026-02-06Hitachi, Ltd. Radiation Oncology Systems, KashiwanohaSoftware anomaly in the patient positioning system may result in positional discrepancy.
2026-02-06Hitachi, Ltd. Radiation Oncology Systems, KashiwanohaSoftware anomaly in the patient positioning system may result in positional discrepancy.
2026-02-03Ion Beam Applications S.A.It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the
2024-07-10Ion Beam Applications S.A.Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
2024-07-08Ion Beam Applications S.A.Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
2024-05-27Hitachi America, Ltd., Particle Therapy DivisionDuring positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are
2024-05-27Hitachi America, Ltd., Particle Therapy DivisionDuring positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are
2024-05-27Hitachi America, Ltd., Particle Therapy DivisionDuring positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are
2024-05-10Ion Beam Applications S.A.Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
2024-03-04Ion Beam Applications S.A.There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.