Reveal 35C X-Ray Detector

Product Description

The Reveal 35C portable dual energy X-ray detector screens and aids in the diagnosis of pulmonary health issues including tuberculosis, lung cancer, COPD, pneumonia, and COVID-19. It is used in a similar manner to conventional digital x-ray detectors.

This product was selected for inclusion in WHO’s 2021 Compendium of Innovative Health Technologies for Low‐Resource Settings.

Distributors / Implementing Organizations

KA Imaging

Manufacturing/Building Method

Unknown

Intellectural Property Type

Patent Protected

User Provision Model

Direct from manufacturer

Distributions to Date Status

Unknown

Clinical application

X-rays

Indispensable equipment for function (Yes/No)

Consumables

Device weight (kg)

3.2 kg

Device dimensions

459.5 x 383.5 x 15 mm

Max power consumption (W)

63 W

Power supply type

Lithium battery

Maintenance or calibration required by user at time of use? (Yes/No)

Yes

Type of technology used for test

X-ray

Time required for procedure

Unknown

Design Specifications

Reveal 35C uses a three layer stacked sensor design to produce three X-ray images using a single conventional chest X-ray exposure. The X-ray images can then be used to generate a conventional digital radiography, a bone subtracted and a soft tissue subtracted X-ray image, and lateral view dual energy X-ray images. The device is intended to be used in a similar way as a conventional digital X-ray detector.

Technical Support

Provided by the manufacturer and trained general technicians

Replacement Components

Lithium battery

Lifecycle

5-10 years

Manufacturer Specified Performance Parameters

Enable bone and soft tissue images in a single X-ray exposure

Vetted Performance Status

There is an ongoing lung cancer clinical trial with 30 patients at Grand River Hospital and a second, IRB-approved COVID-19 clinical trial with 600 patients with Princess Margaret Hospital and University of Toronto that began in June 2020. The product has since been FDA 510(k) cleared and Health Canada approved and is available for sale in the USA and Canada. Reveal 35C has also been certified under several performance standards.

Safety

Standard precaution with X-ray devices of safety factors such as radiation exposure should be taken

Complementary Technical Systems

A laptop or computer is needed to operate the device, an anti scatter grid can be supplied upon request

Academic Research and References

Fredenberg, E., 2018, “Spectral and dual-energy X-ray imaging for medical applications.” Nuclear Instruments and Methods in Physics Research, Vol. 878, pp. 74-87.

Maurino, S. L., Ghanbarzadeh, S., Ghaffari, S., and Karim, K. S., 2019, “Novel multi-energy x-ray detector allows for simultaneous single-shot acquisition of digital radiography and tissue-subtracted images.” European Congress of Radiology-ECR.

Wong, H. Y. F., et al., 2020, “Frequency and distribution of chest radiographic findings in patients positive for COVID-19.” Radiology, Vol. 296(2), pp. 72-78.

Compliance with regulations

EC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment — Part 1 IEC 60601-1-2:2014 (Ed 4.0) Medical electrical equipment — Part 1-2 ISO 14971:2007 Medical Devices - Application Of Risk Management To Medical Devices IEC 62220-1-1 Edition 1.0 Medical Electrical Equipment-Characteristics Of Digital X-Ray Imaging Devices Part 1-1

Other Information

None