(160 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Peripheral Vascular.
The Perception's GPS-RST Ultrasound System is a PC (computer) based and controlled real time, two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-RST Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-RST Diagnostic Ultrasound System supports M, B, M&B, Dual B, Quad B. D and D/B, display modes. All probes currently intended for use with the Perception GPS-RST Diagnostic Ultrasound System are either mechanical sector devices or electronic linear array, and make use of a fluid filled design.
The provided 510(k) summary for the Perception Inc. GPS-RST Diagnostic Ultrasound System does not contain information regarding acceptance criteria for clinical performance or any clinical study to prove the device meets such criteria.
The document states "Discussion of Clinical Test Performed: Not Applicable" {3}, indicating that no clinical tests were performed for this submission. The 510(k) focuses entirely on non-clinical testing to demonstrate substantial equivalence to predicate devices, primarily concerning acoustic output and electrical safety standards.
Therefore, I cannot populate the requested tables and information regarding acceptance criteria and clinical study details. The document explicitly declares that no clinical tests were conducted.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.