(17 days)
The IMPAX MA3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).
The IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images.
The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.
IMPAX MA3000 is a diagnostic softcopy breast imaging workstation with diagnostic print capability.
The following features are available:
· Display and printing of regionally approved DICOM DR Digital Mammography Images
(MG SOP class)
· Display and printing of regionally approved DICOM CR Digital Mammography Images
(CR SOP class)
The Hardware configuration of Embrace™ will consist of the following:
Dell Precision™ Workstation 650; System (Per Host Machine): Compaq xw6000
Number & Details of CPU's 1 or 2 CPU's depending on configuration
Hard Drive space: 40GB IDE
CD-ROM: Yes
Floppy: Yes
Network interfaces: System comes with an integrated 10/100/1000 Ethernet adapter
Power Supplies: Default
Chassis: Tower
Peripherals: Microsoft IntelliMouse or IntelliMouse Explorer; Keyboard
Embrace™ will support the following monitors:
- BARCO Mammography MeDis 5MP CRT monitor package MGD . 521M
- . BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU)
The provided text is a 510(k) summary for a PACS workstation and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document describes the device name, classification, indications for use, and a comparison to predicate devices, focusing on substantial equivalence for regulatory approval. It does not include details on performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the requested study information.
§ 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).