Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLCThe Alturion Series Diagnostic Ultrasound System by Philips Ultrasound LLC is an advanced diagnostic ultrasound system designed for a wide range of clinical applications. It uses AI technology to improve workflow efficiency with features like AI Auto Measure Abdomen, which automates measurements of abdominal organs. This system supports multiple ultrasound imaging modes and is intended for use by trained healthcare professionals in clinical settings, aiding in accurate and efficient patient diagnosis.
Intended Use
The Alturion Series Diagnostic Ultrasound System is indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body in the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Technology
The device is a software-controlled diagnostic ultrasound system consisting of a system console and transducers. It supports multiple imaging modes including B-mode, M-mode, Doppler, 3D/4D imaging, and harmonic imaging. The Alturion Series includes an AI Auto Measure Abdomen feature to automate measurements in abdominal exams. The system uses common software architecture from the predicate Affiniti Series with improved acoustic capabilities.
Performance
Non-clinical verification testing includes IEC and ISO standards for medical electrical safety, software lifecycle, ultrasound field characterization, biocompatibility, and risk management. Performance validation of the AI Auto Measure Abdomen feature was conducted using ultrasound images from 150 subjects, comparing AI measurements to manual expert measurements, showing strong concordance within acceptance criteria.
Predicate Devices
No predicate devices specified
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