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X-ray Imaging System (XIS)

FDA UDI

Class II (US FDA UDI)

by Ehmetdx, LLC

Identity

Trade Name
X-ray Imaging System (XIS) FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
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 FDA UDI
Model / Reference
v.1.x FDA UDI
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 FDA UDI

Identifiers

Catalog Number
n/a FDA UDI
Primary DI / UDI-DI
00866854000401 FDA UDI
510(k) Number
K181498 FDA UDI
FDA Product Code
LHN FDA UDI
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CT system application software

X-ray Imaging System (XIS) by Ehmetdx, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CT system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ehmetdx, LLC

Sources (1)

  • FDA UDI c23570d6-5694-4d63-9680-1bd12b2fb0a7 35 fields · synced May 30, 2026