FDA grants 510(k) clearance to 3DISC for FireCR Medical Scanners and QuantorMed Imaging Software

3DISC, a manufacturer of high-quality, affordable computed radiography solutions, has received 510(k) clearance from the U.S. Food and Drug Administration to market its line of FireCR Medical Scanners and QuantorMed Imaging Software in the United States. The unique FireCR Scanners can be quickly upgraded to higher speeds with a simple smart card update, giving users flexibility to start with an entry‐level scanner and increase productivity as their needs change.

“Busy hospitals, clinics, and practices today need maximum flexibility in selecting imaging equipment and also need to ensure that their technology investment is protected”

3DISC's FireCR Scanners represent the next generation in CR reader technology—providing maximum flexibility and a fast return on investment for hospitals, busy clinics, specialty practices, and satellite facilities. They can be configured for most medical and chiropractic applications and are designed for full DICOM connectivity, allowing users to capture high-quality X-ray images of any body part. 3DISC's companion QuantorMed Imaging Software provides optimized image acquisition, processing, and management capabilities. Autocalibration technology ensures stability and consistency, even when the scanners are wheeled around a busy clinic on a cart or transported in a mobile imaging unit.

According to Sigrid Smitt-Jeppesen, chief executive officer of 3DISC Americas, the company is the first and only manufacturer to offer the ability to upgrade its CR readers. "Busy hospitals, clinics, and practices today need maximum flexibility in selecting imaging equipment and also need to ensure that their technology investment is protected," Smitt-Jeppesen said. "3DISC answered that call by developing the first line of CR readers that can be quickly upgraded in the field without having to replace equipment, ensuring no disruption in workflow and providing maximum value. We are committed to bringing the benefits of digital imaging to healthcare facilities of all sizes and types, and the recent FDA clearance of our FireCR Scanners and software is an important milestone along this journey."

The compact, lightweight FireCR Scanners are designed to fit into any environment, with a wall-mount option for facilities with limited space availability. At just 5 inches deep and 65 pounds, they can fit in the smallest of X-ray rooms, so technologists no longer have to leave the room—and the patient—in order to scan X-rays, preventing workflow disruptions and improving patient care and satisfaction.

The FireCR Medical product line, which is being used by a growing number of facilities in Europe, is available in the U.S. immediately through a global network of distributors. It includes a range of compact, portable CR readers designed for specific clinical applications, including:

  • FireCR Medical - 80 CR Scanner for hospitals, back-up units, and private clinics
  • FireCR Medical - 60 CR Scanner for private clinics and high-volume practices
  • FireCR Medical - 40 CR Scanner for mid-volume practices
  • FireCR Medical - 20 CR Scanner for lower-volume practices
Source:

3DISC

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