CCD-based device already installed at 22 global sitesAnother digital x-ray device has received Food and Drug Administration 510(k) clearance, and it comes from an unexpected source. X-ray OEM equipment supplier Advanced Instrument Development
CCD-based device already installed at 22 global sites
Another digital x-ray device has received Food and Drug Administration 510(k) clearance, and it comes from an unexpected source. X-ray OEM equipment supplier Advanced Instrument Development announced last month that it has received the FDA's go-ahead to market Imix 4000M, a CCD-based chest radiography system developed by Finnish firm Imix (SCAN 4/16/97).
Imix 4000M features a 40 x 40-cm detector with a 2K x 2K matrix and resolution of 2.5 line pairs/mm. Imix 4000M employs a 16-bit processor to acquire image data, and can capture and display an image in 10 sec, according to AID X-Ray. The unit employs only one CCD panel, which is sufficient in terms of resolution and image quality, according to Thomas Spees, vice president of marketing and sales for AID X-Ray.
The system's Windows NT-based control station is powered by a Pentium II processor, and includes Imix's acquisition and postprocessing software. Users can store up to 300 images on the acquisition computer, Spees said. The system is also DICOM 3.0-compatible, he said.
While no clinical testing of Imix 4000M has been done in the U.S., the unit has been selling in Europe and other regions since the third quarter of 1997, and has been installed at 22 sites in countries such as Finland, Norway, Sweden, Germany, Italy, Hungary, and South Africa. AID X-Ray demonstrated the product at last year's Radiological Society of North America meeting, and filed its 510(k) submission shortly thereafter. Clearance was granted on March 19.
In a departure from its traditional OEM distribution approach, AID X-Ray is forming a network of dealers and distributors to sell Imix 4000M to end users. The Melrose Park, IL-based company has already signed up dealers in New York and Texas, and is aggressively looking to add on dealers in other areas, Spees said. Spees expects 50% of the distribution network to be in place within three months.
While a list price has not yet been determined, it is expected to be under $200,000, Spees said. Both the distribution network and AID X-Ray will handle service, he said.
Imix is a division of Tampere, Finland-based x-ray equipment provider Medira Group, and was formed in 1994 to develop and commercialize digital radiography products. Imix has granted exclusive manufacturing and distribution of its products in the U.S. to AID X-Ray.
AID X-Ray will soon be able to sell at least one more system from Imix. The Finnish firm is actively working on developing a tabletop unit. AID X-Ray expects to be able to file for FDA 510(k) clearance for that system by the fourth quarter of this year. Imix is also investigating the technology for use in dedicated mammography and fluoroscopy applications, although no plans have been set for commercialization of the technology, Spees said.