(171 days)
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations.
The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's "EchoPAC Software Only / EchoPAC Plug-in." It describes the device, its intended use, and compares it to predicate devices. However, it explicitly states:
"The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence."
This means the document does not contain information about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, or adjudication methods because clinical studies were not deemed necessary for this submission. The submission relies on non-clinical tests and comparison to previously cleared predicate devices.
Therefore, I cannot provide the requested information from the given text.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).