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FDA-cleared K212704

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

Philips Medical Systems

Authorized purpose: Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are general-purpose diagnostic ultrasound systems for imaging and analysis across the labeled fetal, abdominal, pelvic, small-organ, cephalic, cardiac, vascular, musculoskeletal, thoracic, and urologic applications.

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2021-09-24
FDA-cleared K211597

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Philips Medical Systems

Authorized purpose: EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems are general-purpose diagnostic ultrasound systems for the labeled fetal, abdominal, pelvic, small-organ, cephalic, cardiac, vascular, musculoskeletal, thoracic, and urologic applications by trained professionals.

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2021-09-08