(56 days)
The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthicare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Vascular Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/ Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD. B/Power/PWD or CWD.
The device is intended for use in an indoor hospital environment, in medical offices chilities.
The Versana Active is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The Versana Active is a compact, portable system, the device includes operator control panel, display monitor and transducers. The system provides digital acquisition, processing and display capability. The system can be powered through an electrical wall outlet for long term use or from internal battery for a short time use. The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device. The Versana Active design enables the system to be attached to three kinds of optional mobile carts. The variety of transducers include convex, linear, sector and mechanical 4D. The access tvpes include trans- body surface. transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port connection and with the use of optional Video Output Adapter, the system can have a Composite Out port connection and a S-Video Out port connection. An optional spare battery charger allows the system battery to be charged externally. The system has an option for an external Printer USB Isolator for printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.
The provided text is a 510(k) summary for the GE Healthcare Versana Active ultrasound system. It indicates that no clinical studies were required to support substantial equivalence. Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.
The information provided focuses on the device's technical specifications, comparison to predicate devices, and a summary of non-clinical tests (acoustic output, biocompatibility, cleaning, electrical safety, etc.) that demonstrate compliance with safety standards.
Since no clinical studies were performed, I cannot provide the requested information about acceptance criteria, device performance, or study details.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.