SureWave Elastography (Q7000225)

SureWave Elastography (Q7000225) is an FDA 510(k)-cleared medical device (K242006) manufactured by Quality Electrodynamics, 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 February 11, 2025. Regulation: 8.