GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC radiology AI products

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FDA-cleared K230346

Voluson SWIFT; Voluson SWIFT+

GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC

Authorized purpose: Voluson SWIFT and Voluson SWIFT+ are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals to image, measure, display, and analyze the human body and fluid across the labeled fetal/obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal, transrectal, and transvaginal applications in a hospital or medical clinic.

Modality: Ultrasound
Anatomy: Fetal/obstetric, abdominal, renal, gynecologic/pelvic, pediatric, breast, testes, thyroid, cephalic, cardiac, vascular, musculoskeletal, transrectal, urologic, and transvaginal anatomy
Decision: 2023-06-20