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.This product group from Philips Ultrasound, Inc. includes several series of diagnostic ultrasound systems and software that produce and analyze ultrasound images to assist clinicians in diagnosing various conditions. They support 2D, Doppler, and advanced imaging modes for applications across many body regions, improving clinical workflow and diagnostic confidence.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body in varied clinical applications including abdominal, cardiac, cerebral vascular, musculoskeletal, fetal/obstetric, gynecological, and small organ imaging.
Technology
Ultrasound systems use electrical current to stimulate piezoelectric transducer elements which emit and receive sound waves. The systems process echo signals to generate real-time images displayed to users. Multiple transducer types support imaging of different anatomies. QLAB software quantifies image data for advanced analysis.
Performance
No new performance testing data is required; devices are substantially equivalent to predicate devices with no changes in software, hardware, or intended uses. Performance and safety are supported by established design control measures.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/17/2020
14 days - 2
FDA Approval
5/1/2020
Other devices from Philips Ultrasound, Inc.
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