
Atl Ultrasound, Inc.
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HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING is an FDA 510(k)-cleared medical device (K002003) manufactured by Atl Ultrasound, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2000. Regulation: 8.