FDA clears Medison’s SA 8800

Medison America received clearance Aug. 21 for the company's SonoAce 8800 scanner, according to M.T. Kwon, president and CEO of the Pleasanton, CA, company. A collaborative effort between Medison and development partner ATL Ultrasound of Bothell, WA, SA 8800 is a mid-range color Doppler scanner that carries a 64-channel digital beamformer. As an added bonus, the scanner also supports 3-D imaging and can produce qualitative 3-D images in multiple planes or volumes.

ATL will sell the unit as HDI 1500 and expects to list it between $70,000 and $100,000. Medison and ATL entered into partnership earlier this year to develop and distribute mid-range digital ultrasound scanners (SCAN 5/13/98), and HDI 1500 evolved from the cooperative efforts of the two companies.

In other Medison news, the company has received 510(k) clearance for a power Doppler mode for Combison 530D, the firm's integrated 3-D ultrasound scanner.