In a move that the company said “opens the door for computed radiography [CR] to be more available to healthcare providers nationwide,” the FDA has granted Radlink (Redondo Beach, California) clearance for the sale and distribution of its CR Pro machine.

Radlink said the system has been in development for two years, and the company exhibited the CR Pro at the recent annual meeting of the Radiological Society of North America (Oak Brook, Illinois) at Chicago’s McCormick Place convention center.

“We have two products on the market currently, one of which was cleared by the FDA that is a digitizer, a machine that simply processes X-ray film and converts it into digital [images],” CEO Thomas Hacking told Diagnostics & Imaging Week. “The other products we have are related software applications that we sell independently, and those don’t need FDA approval.”

The CR Pro system uses Radlink’s sealed fiber-optic laser technology to deliver what it called “high-resolution, diagnostic-quality images that provide long-term image quality.”

“What our CR machine does is eliminate the entire step that converts image to film,” Hacking said. “We eliminate film altogether.”

The CR Pro works by taking the cassette used to take a typical X-ray and placing it in a slot in the CR Pro. In about 20 seconds, the CR Pro reads the X-ray. The image appears as a digital image on a monitor directly on the device, and the technician looks at X-ray as a digital image, not as film, he said.

“It can be emailed via the Internet anywhere you want, [and] any number of other physicians can look at it exactly [at] that moment,” he said, noting that it can also be stored on the device.

Because the CR Pro is mobile, it can travel anywhere within a physician’s suite of offices, Hacking said. Also, when high-priced real estate is taken into consideration, the fact that a doctor’s office would no longer have to store film equals money saved in leasing costs.

Also, whereas competitors’ machines cost in the range of $100,000 and above, CR Pro uses the fiber optic process, “which is different than the process used by our competitors,” and offers cost savings, he said.

“The true breakthrough of CR Pro is that it is built on a platform that allows it to be sold at a substantially lower cost than all of its competitors, finally making computed radiography systems available to healthcare providers who have previously been unable to afford the technology,” Hacking said in a statement.

He added, “We believe that our proprietary laser technology will not only compete favorably in the U.S. on price, but we also believe it’s superior to the existing standard, because it provides enhanced resolution to the scanned image and as a result, X-rays can be viewed more clearly.”

Radlink now has four salespeople. However, Hacking said the company plans to sell its devices through dealers and picture archiving and communications systems companies. The company has a group of “master dealers.”

“The master dealers are responsible for servicing, if you will, after the fact, if necessary,” he said. “We hope that’s not necessary, but we want to have that in place, anyway.”

Managing the sub-dealers and their regions also is the responsibility of the master dealers.