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Sapheneia / Scannerside Announces FDA 510(K) Clearance for New 2nd Gen XR 29 Dose Check

KEYSTONE, Colo., Sept. 5, 2017 /PRNewswire/ -- Sapheneia and Scannerside received FDA 510(k) clearance to market their XR-29 DoseCheck solution. Scannerside DoseCheck is a third-party Vendor neutral CT product that makes it affordable to update existing CT scanners and allows compliance with current MITA standards.

The Sapheneia-Scannerside proprietary XR 29 DoseCheck solution is specifically designed to provide CT operators, prior to a scan, notifications and alerts of potential radiation doses over a predefined threshold. Scannerside Dose Check is intended to be installed and used with CT scanners not equipped with these functionalities, independent of age, make, and model. This newly introduced DoseCheck system encompasses a proprietary hardware and software solution with additional features that NO other third-party solution can offer. "We believe the latest comprehensive solution will be the backbone to solving XR25/29 and beyond upgrades for legacy Scanners," says Paul Stashick, CEO Sapheneia Inc.

Sapheneia has a long successful history of low-dose applications for CT users, since being the first third-party software company that received FDA clearance for the Clarity low-dose software (2007).  Sapheneia Inc. and Scannerside became business partners, combining Low Dose CT (LDCT), Dose Monitoring, and XR-29 scanner upgrades, thereby becoming the first Single Source CT Dose solution provider.

Now that Scannerside DoseCheck has been FDA 510(k) approved the partnership between Sapheneia-Scannerside can help a facility reach all the requirements for XR-29 compliance. 

Sapheneia Inc. is a U.S. technologies company specializing in diagnostic and analytical image processing solutions. For more than a decade, Sapheneia software has been in routine, clinical use at major hospitals and imaging centers worldwide, supporting CT scanner systems from all manufacturers, including GE, Philips, Siemens, and Toshiba. The solutions provided by Sapheneia range from its Comprehensive Dose Strategy (CDS) for X-Ray, NM and CT to supplying some of the world's largest equipment manufacturers with software for ultrasound and other modalities.

Scannerside hardware/software solutions are created by academic radiologist. With the objective of creating practical solutions by doctors for doctors. Scannerside continues its forefront market position by monitoring compliance laws and building applications that satisfy the current legislation with rapid product deployment.

Paul Stashick 

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SOURCE Sapheneia Inc.
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