(179 days)
The intended use of this software package is to render 3-dimensional images from a series of Computer Tomography cross sectional images.
The Acculmage software processes and displays digital image data obtained in either DICOM 3.0, ACR-NEMA 2.0 format or in Imatron Proprietary format. System options include the ability to input data either through a standard Ethernet connection or through the UPOW port of the Imatron C100 and C150 series of Ultrafast Electron Beam CT Scanners.
The provided text does not contain any information about acceptance criteria for device performance, a study to prove it meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) summary for a medical device (AccuImage, Inc. Image Display Processor), primarily focusing on:
- Company Identification: AccuImage, Inc.
- Device Name: AccuImage, Inc. Image Display Processor
- Substantial Equivalence: Claiming equivalence to Cemax VIPStation and/or Software (K945188).
- Device Description and Intended Use: Rendering 3D images from CT scans.
- Software Development: Stating the software is developed, tested, and validated according to written procedures.
- Substantial Equivalence Comparison Chart: Comparing features of the AccuImage AIDP2.1 with the Cemax VIP system.
The comparison chart details technical specifications and features of the software (e.g., network connectivity, computer platform, image formats, image processing capabilities, volume rendering techniques), but it does not specify any performance metrics, thresholds, or clinical study results.
Therefore, I cannot provide the requested information based on the input text.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.