Updated on February 8, 2024

·

Created on June 13, 2017

Clarius Ultrasound

Upcoming Update

The Clarius Ultrasound is an app-based, wireless, handheld ultrasound scanner.

Developed By
  1. Clarius
Content Partners
Unknown

Author

Product Description

The Clarius Ultrasound is an app-based, wireless, handheld ultrasound scanner. The Clarius C3 is made for performing ultrasound scans of the abdomen and lungs and also features a virtual phased array for quick scans of the heart. The other device is the Clarius L7, and Clarius L15 a procedural guidance and superficial imaging scanner.

Market Suggested Retail Price

$4,900.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Distributed by manufacturer

Competitive Landscape

Manufacturing/Building Method

This product is mass-produced by Clarius.

Intellectural Property Type

Patent

User Provision Model

Users can obtain the product from the Clarius Website. Clarius Scanners are also available from a network of distribution partners in parts of Europe and the Middle East. The Clarius Ultrasound App can be downloaded from the Google Play Store or Apple Store.

Distributions to Date Status

Unknown

Power supply type

Rechargeable batteries (charger included), iPhone or Android

Consumables

Ultrasound gel. Depending on the country of purchase, the product may also include a one-time use sachet for the ultrasound gel.

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

No

Scanning modes

2D, color doppler (available for certain devices), virtual phased-array

Clinical application

Abdominal, lung, cardiac, procedural guidance

Display

iOS or Android device

Probe frequency (MHz)

For the C3: 2-6 MHz, for the L7: 4-13 MHz, for the L15: 5-15 MHz

Design Specifications

The Clarius ultrasound is a handheld ultrasound scanner that can operate as a standard convex array probe to image the abdomen and lungs, and a virtual phased array probe for cardiac imaging. In-detail product specifications can be found on the website. C3 1st generation: Curvilinear Scanner

  • Frequency: 2 - 6 MHz
  • Max depth: 32 cm
  • Weight: 540 g
L7 1st generation: High frequency linear
  • Frequency: 4 - 13 MHz
  • Max depth: 7 cm
  • Weight: 540 g
L15 HD: High frequency linear
  • Frequency: 5 - 15 MHz
  • Max depth: 7 cm
  • Ideal for: Nerve, breast, MSK, thyroid, small parts
 

Product Schematics

Technical Support

Clarius provides technical support through their website. The device includes automated gain and frequency settings which eliminate the need for calibration by the user at the time of use.

Replacement Components

Clarius provides spare or replacement components, referenced in their product terms and conditions.

Lifecycle

Three-year warranty, five-year lifetime.

Manufacturer Specified Performance Parameters

The team set out to design a low-cost portable handheld ultrasound that produces image quality comparable to that of a much more expensive device (~70,000 USD).

Vetted Performance Status

Clinical trials and studies have been carried out including a phantom study to validate a novel 3D handheld ultrasound system in imaging scoliosis and carried out clinical trials to assess equivalency of the transabdominal Clarius handheld wifi C3 ultrasound.

Safety

Instructions and warnings to use the product safely can be found on the user manual. Several studies were carried out to ensure that the device is safe for in clinical applications.

Complementary Technical Systems

iOS or Android device, Clarius app

Academic Research and References

Lou, E., Nguyen, D., Hill, D., & Raso, J., 2021, “Validation of a novel handheld 3D ultrasound system for imaging scoliosis–phantom study,” In Research into Spinal Deformities 9 IOS Press, pp. 100-105.

Winiker, K., et al., 2021, “Ultrasound: Reliability of a Pocket-Sized System in the Assessment of Swallowing,” Journal of Speech, Language, and Hearing Research, 64(8), pp. 2928-2940.

Moussaoui, G., Zakaria, et al., 2021, “Accuracy of Clarius, Handheld Wireless Point-of-Care Ultrasound, in Evaluating Prostate Morphology and Volume Compared to Radical Prostatectomy Specimen Weight: Is There a Difference between Transabdominal vs Transrectal Approach?,” Journal of Endourology.

Dickie, K., 2019, “Wireless ultrasound,” Clarius White Paper, pp. 1-4.

Hammond, R., 2020, “A pilot study on the validity and reliability of portable ultrasound assessment of swallowing with dysphagic patients, ” Canterbury.

Alsinan, A. Z., Patel, V. M., & Hacihaliloglu, I., 2019, “Automatic segmentation of bone surfaces from ultrasound using a filter-layer-guided CNN,” International Journal of computer-assisted radiology and surgery, 14(5), pp. 775-783.

Stuart, F., James, M., Mark, L., et al., 2009, “A New 15–50 MHz Array-Based Micro-Ultrasound Scanner for Preclinical Imaging,” Ultrasound in Medicine & Biology, Vol. 35, pp. 1700-1708.

Mawia, K., Katherine, B., Kevin, J., Kenneth, H., 2019, ‘Real-time H-scan ultrasound imaging using a Verasonics research scanner,” Ultrasonics, Vol. 94, pp. 28-36.

Clarius, “Patents and Trade market

Clarius, “Warranty

PR Newswire, “Clarius Wireless Ultrasound Receives FDA 510(k) Clearance“, 2016

Clarius, “App: Google Play and App Store

Compliance with regulations

Devices are FDA-cleared and the Company is ISO certified

Evaluation methods

The device was evaluated through a phantom study, clinical trials, and other several clinical studies.

Other Information

The scanner uses point-to-point Wi-Fi and Bluetooth to operate. You will need an Internet connection initially to download the Clarius App to your Android or iOS smart device and if you want to save images to the Clarius Cloud or transmit images via DICOM (available mid-2017). To use the scanner outside an existing wireless network, select "Wi-Fi Direct" in the scanner selection page (this is the default option), and once booted, the App will prompt you to connect to the Wi-Fi Direct network of the scanner.

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