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FDA-cleared K201012

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

Philips Ultrasound, Inc.

Authorized purpose: The K201012 labeling covers Philips EPIQ, Affiniti, CX50, Sparq, and Lumify diagnostic ultrasound systems plus QLAB image viewing and quantification for labeled abdominal, cardiac, vascular, obstetric, gynecologic, pediatric, musculoskeletal, small-organ, urologic, intraoperative, and other ultrasound workflows.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2020-05-01