LUX-Dx II (M302); LUX-Dx II+ (M312)

LUX-Dx II (M302); LUX-Dx II+ (M312) is an FDA 510(k)-cleared medical device (K231328) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 2023. Regulation: 8.