The Food and Drug Administration has put the final regulatory pieces together for South Koreanultrasound vendor Medison. After a rather prolonged wait, theagency cleared Medison's SonoAce 4800 scanner, a gray-scale Dopplersystem that will be Medison's
The Food and Drug Administration has put the final regulatory pieces together for South Koreanultrasound vendor Medison. After a rather prolonged wait, theagency cleared Medison's SonoAce 4800 scanner, a gray-scale Dopplersystem that will be Medison's premium scanner until the introductionof a color-flow Doppler unit some time in the future, accordingto Mark Hayward, president of Medison's U.S. subsidiary in Pleasanton,CA. Two other Medison systems were cleared last year, with SonoAce4800 the last of the vendor's scanners in the FDA's review process(SCAN 2/2/94).
SonoAce 4800 is a convex, linear, mechanical and pulsed Dopplersystem that will be targeted at vascular and abdominal applications.Medison will handle direct sales and will market the system primarilyto the in-office ultrasound market. List price of SonoAce 4800with Doppler, two probes and a printer is $38,900. Medison marketsa color-flow Doppler unit in Korea and plans to bring that scannerto the U.S., Hayward said.
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