Alara™ CRystalView™ Cleared by FDA

Hayward, CA, October 27/PRNewswire/ - Alara Incorporated announced it has received 510(k) clearance from the Food and Drug Administration (FDA) to market its CRystalView desk-top computed radiography (CR) system. The CRystalView system uses storage phosphor technology to replace film in conventional medical x-ray systems and provides high quality digital images at an affordable price.  

The current digital x-ray market for the U.S. is estimated to be approximately $1.5 billion.   Most users of digital imaging systems have been large hospitals and clinics who seek the benefits of improved image quality, reduced labor costs and more efficient workflow. The high cost of converting from film-based systems, however, has prevented many smaller hospitals and clinics from reaping the same benefits.  

"The CRystalView is designed to provide first rate image quality at a practical, reasonable price for clinics and office suites with multiple x-ray rooms,' said Charles Cantoni, President and CEO of Alara.   

The Alara CRystalView system is provided in a true desk-top configuration that provides maximum flexibility for users. The system automatically unloads, scans, erases and re-loads the storage phosphor imaging plate which takes the place of conventional film. Scanner throughput is in excess of 50 plates/hour for 14" x 17" cassettes in standard (6 pixels/mm) resolution. Smaller cassettes are scanned at a higher resolution of 9 pixels/mm. The CR reader itself is a desktop, network scanner that can accommodate up to four quality control workstations operating simultaneously.  

"Now that we've received 510(k) clearance, we're very excited to be introducing the CRystalView system next month at the annual meeting of the Radiological Society of North America (RSNA)," explained Steve Giardina, Vice President, Computed Radiography Division. We believe CRystalView will expand the opportunity for an increasing number of healthcare providers to make the leap to digital imaging technology. CRystalView's flexibility, mobility and performance, significantly enhances work flow for CR applications".

Alara, Inc. is a privately held medical, dental and NDT device manufacturer located in Hayward, CA. The company's ISO 9001-certified manufacturing facility also produces the DenOptix ä line of digital scanners for the Gendex division of Dentsply International, the MetriScan ä peripheral bone densitometer, and a line of filmless x-ray non-destructive testing (NDT) systems. For more information on Alara, see http://www.alara.com.

302-0001-00 Rev. A