In compliance with XR-29 and XR-25 as outlines by MITA/NEMA
RightDose Inc. has manufactured (OEM) the external hardware and software with the oversight by a Licensed and practicing US radiologist (Dr. William Moore). The five basic components of these rules noted above are accordingly in Compliance as they pertain to the following:
- Automatic Exposure Control (AEC): After evaluation of your equipment we can confirmed that this device is capable of performing clinical CT scans using AEC. We can find your device is COMPLIANT with this requirement.
- Reference Protocols: After evaluation of the internal memory and protocol menu of your CT: Console we can confirm there are both pediatric and adult reference protocols. Technologist have specifically been trained to use these protocols. We can find that your device is COMPLIANT with this requirement.
- DICOM Structured Dose Report: DICOM Radiation Dose Structure Reporting: Enables recording of post exam dose information in a standardized electronic format. This information can be included in the patient record, promoting the establishment of diagnostic reference levels, as well as facility dose management and quality assurance.
We can find that your device is COMPLIANT with this requirement. Or 4 Below:
- DICOM SR reports was not available on your CT Console, However, with the addition of Scannerside Dose Monitoring software a structured report is available which follows ACR guidance on reporting requirements of DIMCOM SR reports. Data in this RDSR is transferable to the Patient’s Records. From your CT Console. Thus we can find that your device is COMPLIANT with this requirement.
- Dose Check: Dose Check allows for estimation of radiation dose prior to the scan being performed. In compliance with XR-25 Dose check regulation Dose Notification, and Dose Alerts are available. Dose Check estimates the radiation dose based on 1. Individual patient body habitus and density, 2. CT Scanner specific AEC table estimates 3. Allows for an auditory and visual alert on the scanner console, 4. Causes the CT scanner to pause in the event of a dose alert, and allowing the technologist to change the protocol to decrease radiation dose. After installation of the Dose Check software to your CT Console.
We can find that your device is COMPLIANT with this requirement.
RightDose XR29 allows for hardware and software upgrades allow monitoring/patient reporting and the above features that meet the required features for COMPLIANCE with XR-29 and XR-25 by MITA/NEMA. We further provide an OEM Compliance Certification and OEM Compliance Letter unique to each Scanner for audit purposes as required by CMS and the ACR as an “Additional Provider”, 3rd party software and hardware OEM.
RightDose Inc. XR29 provides a U/L number for the equipment manufactured in the Compliance Letter.
RightDose Inc XR29 upgrades are all external add on to the CT scanner and RightDose Inc. believes there should be NO change in the Scanner warranty.
LIMITED HARDWARE/SOFTWARE WARRANTY.
For a period of two years following the date of initial delivery of the Hard/Software, and subject to the exclusions set forth below, Licensor warrants that the Hard/Software, when
used as permitted under this (EULA) End User License Agreement and in accordance with the
Documentation, shall operate substantially in accordance with the
material specifications set forth in the Operator’s Manual.