(37 days)
The Versana Balance is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
The Versana Balance is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source. The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device. The variety of transducers include convex, linear, sector and mechanical 4D transducers. The access types 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, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other 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) Premarket Notification Submission for the GE Versana Balance Diagnostic Ultrasound System. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, this document does not contain information about acceptance criteria or the results of a study (clinical or non-clinical performance) that proves the device meets specific acceptance criteria for a diagnostic aid AI/CADe/CADx device.
The document states: "The subject of this premarket submission, Versana Balance, did not require clinical studies to support substantial equivalence." This means that the FDA did not require clinical performance studies for this ultrasound system, as it was deemed substantially equivalent to existing predicate devices based on its technical characteristics and intended use.
Therefore, I cannot provide the requested information for an AI/CADe/CADx device based on this document. The Versana Balance is a general-purpose diagnostic ultrasound system, not an AI/CADe/CADx device.
If you can provide a document that describes the clinical performance study and acceptance criteria for an AI/CADe/CADx device, I would be happy to help.
§ 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.