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The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal, Adult cephalic, Cardiac Adult, Cardiac Pediatric, Fetal - OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, testicles, prostate), Transvaginal, Transesophageal (cardiac), Transrectal, Needle Guidance. Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.

The Sonosite PX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging. The system includes a variety of accessories including optional needle guide starter kits. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.

The provided text does not contain information about acceptance criteria for a medical device or a study proving its performance against these criteria. Instead, it is a 510(k) summary for the FUJIFILM Sonosite PX Ultrasound System, establishing its substantial equivalence to previously cleared predicate devices.

The document focuses on:

• Indications for Use: Listing the clinical applications and exam types for which the ultrasound system is intended.
• Technological Characteristics: Comparing the subject device (Sonosite PX Ultrasound System) with its predicate devices (Sonosite PX Ultrasound System K200964 and SonoSite Edge II Ultrasound System K162045) in terms of features like intended use, indications for use (subsets of predicates), transducer types and frequencies, acoustic output, modes of operation, DICOM support, and safety certifications.
• Non-Clinical Tests: Stating that the device underwent evaluations for electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output, conforming to applicable medical device safety standards. It also mentions compliance with specific ISO and IEC standards.
• Clinical Tests: Explicitly stating that clinical studies were not required to support the determination of substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance against them, as it is not present in the given text.

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