Canon gets FDA go-ahead for digital radiography system

Firm to emphasize retrofit sales for flat-panel offering

The looming battle for market share in digital radiography received another participant last month. Canon USA has received Food and Drug Administration 510(k) clearance for an upright version of its Canon Digital Radiography System. Unlike other vendors that have received FDA clearance for digital radiography products, Canon plans to market the system primarily as a retrofit device.

The system, which has also cleared Japanese Pharmaceutical Law and received the European CE Mark, is now available in the U.S., Europe, Japan, and Canada. Like GE's new digital chest x-ray offering and other systems in development (SCAN 11/11/98), Canon's system features an amorphous silicon-based flat-panel digital detector.

The system leverages Canon's amorphous silicon sensor technology, which has been employed in facsimile machines, scanners, and solar-energy panels for the last decade. It offers a full-field, 17 x 17-inch imaging area (2688 x 2688 pixels), and provides 12-bit images with pixel pitch of 160 microns and spatial resolution of 3.1 line pairs per mm. Other components of the system include a control station and operation unit/preview panel.

Within three seconds of capturing the image, the 10.5-inch preview monitor can show a sub-sampled version for quality control and cropping, according to Canon. An electronic, diagnostic-quality image can be ready in 30 seconds. The sensor plate can acquire additional imaging exposures every six seconds.

Clinical testing of the system was performed at the Cleveland Clinic and University of California, San Francisco, according to Canon. Each site has linked the system to its PACS network, said Neo Imai, product manager for Canon USA of Lake Success, NY.

Canon points to the system's smooth integration with PACS networks as a key benefit. It provides native DICOM 3.0 output, integrating into Ethernet 10/100 Base T networks. At this month's Radiological Society of North America meeting, Canon will also show connectivity using DICOM modality work list with IDXRad, a radiology information system from IDX Systems. Connectivity will be demonstrated with Canon's Digital Radiography System and PACS offerings, which are sold by Canon's Gardena, CA-based Astro Business Solutions division.

"After digital images are captured, a message will be sent to the RIS saying that the job is completed," Imai said.

As a relatively small company in the U.S. market, Canon will face stiff competition from companies such as Sterling Diagnostic Imaging of Greenville, SC, and GE Medical Systems of Milwaukee, who have potent distribution channels in place for their flat-panel offerings. Canon will tout the flexibility and vendor-neutral aspects of the retrofit strategy in order to compete with these firms.

Unlike most of the other vendors seeking to enter the digital radiography market, Canon does not offer x-ray film or generators, so potential customers could integrate Canon's system into their existing x-ray room and PACS infrastructure, Imai said.

"When customers want to introduce digital radiography technology to their radiology department, they obviously want to use existing x-ray rooms and existing x-ray tubes, and a PACS network," he said. "Our system is flexible so they don't have to buy the whole system, including generators and tables."

If customers desire, they could also purchase a complete system, including a generator and tube, from Canon's dealers, who sell and integrate these items from other companies such as Trex Medical of Danbury, CT, and Shimadzu Medical Systems of Torrance, CA, said Tony Shinohara, director and general manager of medical products.

List price for Digital Radiography System will be about $240,000. If a customer purchases a complete system, including tube and generator, Canon estimates the cost between $300,000 and $350,000. This is in line with estimates of other companies marketing digital radiography systems.

Sales will be conducted through a mix of direct and dealer sales. The firm will market directly to luminary sites, with a dealer network handling the remaining potential clients. The dealer network is expected to be in place at this month's RSNA meeting. In addition to these efforts, Canon is in negotiations for an OEM distribution opportunity, Shinohara said.

In addition to its upright system, Canon plans to commercialize a table-based version soon. The company expects to receive FDA clearance in early 1999, Imai said. Canon will also demonstrate a retrofit bucky with its flat-panel sensor unit. Availability is expected in mid-1999, he said. Down the road, Canon plans to apply its flat-panel technology to mammography and fluoroscopy systems, although the firm declined to provide a time line for commercialization of those systems.