Konica Minolta REGIUS Sigma CR Reader Gets FDA Clearance

Konica Minolta REGIUS Sigma CR Reader Gets FDA Clearance

REGIUS ? delivers a compact and affordable imaging solution that maintains the superior image quality and reliability expected from our REGIUS family of products.Combined with the redesigned ImagePilot software,the REGIUS ? provides simple operation and smooth workflow to a wide range of medical practitioners.

1) Lowest Weight CR (approx. 28kg)

2)Power consumption is less than one tenth of prior models.

3)Smallest carbon footprint – CO2 emissions reduced by more than 64% (Calulated at lifecycle, compated to our conventional CR)

Konica Minolta Medical Imaging announced today the REGIUS Sigma has received 510(k) clearance from the US FDA.

The REGIUS Sigma is a new tabletop CR reader and is an ideal, affordable solution for lower volume clinics and practices, including orthopedic, chiropractic and veterinary.

The new REGIUS Sigma tabletop CR reader has a small footprint (20”W x 24”D x 14”H) weighing less than 70 pounds with flexible plate technology that enhance its compact design and cost effectiveness. As with all Konica Minolta CR readers, it is designed for ease of use and reliability with very few replacement parts.

“With the 510(k) clearance of the REGIUS Sigma, Konica Minolta can now offer a more affordable imaging solution to low-volume sites, further extending the footprint of digital radiography to virtually any practice or clinic,” says Steven Eisner, Senior Marketing Manager for Konica Minolta. “With the continued push toward electronic medical records, it is very important for all imaging sites regardless of size to have an affordable method to capture, view, archive and collaborate with colleagues. ImagePilot Sigma is the answer to their digital imaging needs.”

With the FDA clearance, Konica Minolta now offers two versions of the ImagePilot to meet the varying needs of the outpatient and alternate care markets. In addition to the newly cleared REGIUS Sigma, ImagePilot is available with the REGIUS 110 reader geared for higher volume practices and clinics. Standard with any all-in-one ImagePilot configuration is the AutoPilot automatic image processing for unsurpassed consistency in image quality, simplified image acquisition with single click workflow, a common user interface and a feature-rich viewing station that includes image adjustments, annotations, measurements, inputs and outputs and the option to customize for basic to advanced users.

ImagePilot Sigma can also be combined with Informity—Konica Minolta’s cloud-based archive, disaster recovery, image sharing and information portal solution. With Informity, users can collaborate with referring physicians and other specialists; receive remote support including software updates and virus protection, and access service and support history and status.

Konica Minolta has received FDA 510(k) clearance for its REGIUS Sigma tabletop Computed Radiography (CR) reader. The device, about the size of a small consumer laser printer (20” x 24” x 14”), has a maximum resolution of 4020×4892 pixels and supports pixel sizes of 87.5?m and 175?m.

Source : http://www.medicexchange.com/Konica-Minolta-Medical-Imaging-USA-Inc/konica-minolta-regius-sigma-receives-fda-clearance.html

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