Trex prepares for full-field 510(k) filing
X-ray vendor Trex Medical (Hall A, #3500) has completed the clinical trials required for a regulatory submission of its full-field digital mammography detector and is planning to submit a 510(k) filing for the product some time around the RSNA show,
X-ray vendor Trex Medical (Hall A, #3500) has completed the clinical trials required for a regulatory submission of its full-field digital mammography detector and is planning to submit a 510(k) filing for the product some time around the RSNA show, according to Hal Kirshner, CEO and president of the Danbury, CT, company. Trex plans to offer the CCD-based detectors as retrofits to installed Lorad and Bennett mammography units.
Trex will display the latest clinical images acquired with the detectors at multicenter clinical trials used to support the FDA filing. In the trials, 520 patients were examined, and the studies were being read in the weeks up to the RSNA conference. Clinicians participating in the trials will also be present to discuss their findings.
Farther down the product pipeline are flat-panel digital detectors, which Trex will display in its RSNA booth as works-in-progress for general radiographic systems manufactured by its Bennett and Continental subsidiaries. In addition to static x-ray studies, Trex plans to develop versions for fluoroscopy and cardiac cath applications, and will show a demonstration of the panels used for 30 fps imaging.
The flat-panel devices are about a year from a regulatory submission, Kirshner said. Trex also plans to develop a flat-panel digital mammography detector, although that project is not as urgent because the company's CCD-based product is about to reach the market.
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