Philips Ultrasound radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K232500

Lumify Diagnostic Ultrasound System

Philips Ultrasound

Authorized purpose: Lumify is a general-purpose ultrasound system using compatible Android devices and USB transducers; K232500 adds AI-assisted automatic ejection-fraction quantification.

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2023-10-26

Quantification and segmentation Ultrasound workflow

FDA-cleared K223771

Lumify Diagnostic Ultrasound System

Philips Ultrasound

Authorized purpose: The K223771 Lumify system acquires diagnostic ultrasound data in B, color, combined, pulsed-wave Doppler, and M modes for trained clinicians across fetal and obstetric, abdominal, pediatric, cephalic, urologic, gynecologic, small-organ, musculoskeletal, vascular, cardiac, lung, and procedural workflows; the submission adds an Expanded B-lines software feature.

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2023-05-04

Cardiac imaging Ultrasound workflow