The 5000 Compact Series Ultrasound Systems

The 5000 Compact Series Ultrasound Systems is an FDA 510(k)-cleared medical device (K242800) manufactured by Philips Ultrasound, 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 November 14, 2024. Regulation: 8.