(35 days)
Ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic. Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletat, Great Vessel, and Peripheral Vascular applications.
The Siemens Acuson X500 has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment IEC 60601-2-37 Diagnostic Ultrasound Safety Standards CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment . AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound 93/42/EEC Medical Devices Directive t Safety and EMC Requirements for Medical Equipment EN/IEC ୧୦୧01 - I . EN/IEC 60601-1-1 EN/IEC 60601-1-2 IEC 1157 Declaration of Acoustic Power l ISO 10993-1 Biocompatibility
This is a 510(k) Pre-market Notification for the Siemens Acuson X500 Ultrasound System. It is an application for market clearance rather than a post-market study reporting performance against acceptance criteria. Therefore, the document does not contain the specific information required (acceptance criteria, specific study details proving performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The "Performance Data" section states: "The X500 modifications are verified and validated according to the company's design control process." This indicates that internal testing was performed to ensure the device met its design specifications and regulatory requirements, but the details of these tests are not provided in this summary.
The tables provided are "Diagnostic Ultrasound Indications for Use Forms" for the main system and various transducers. These tables outline the intended uses and the modes of operation for which the device and its components are cleared, indicating what the device is designed to do, not how well it performs against specific metrics or what studies prove that performance.
Therefore, I cannot provide the requested information from this document. This document primarily serves as a declaration of substantial equivalence to a predicate device and outlines the intended uses of the various components of the ultrasound system.
§ 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.