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FDA-cleared K251106

Sonosite LX and Sonosite PX Ultrasound Systems

Fujifilm Sonosite Inc

Authorized purpose: Sonosite LX and PX ultrasound systems acquire, display, analyze, and support needle guidance for the labeled general, cardiac, vascular, abdominal, obstetric, and procedural examinations.

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; vessels; musculoskeletal anatomy; and other labeled ultrasound applications
Decision
2025-08-29