ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 is an FDA 510(k)-cleared medical device (K040926) manufactured by Hudson Diagnostic Imaging, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 2004. Regulation: 8.