FDA Clears Siemens ACUSON Sequoia, Select, Origin, and Origin ICE Ultrasound Systems

FDA granted 510(k) clearance to Siemens Medical Solutions for its ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE diagnostic ultrasound systems (product code IYN). The clearance permits U.S. marketing of these general imaging platforms.

• The clearance spans the cart-based Sequoia/Select/Origin and the Origin ICE (intracardiac echocardiography) variant, unifying the updated ACUSON family.
• The devices are classified as radiological diagnostic ultrasound systems under FDA product code IYN.
• A 510(k) clearance evaluates substantial equivalence to a predicate device; it does not independently validate clinical superiority or new indications.

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