AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
Device Facts
| Record ID | K961023 |
|---|---|
| Device Name | AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) |
| Applicant | Accuimage, Inc. |
| Product Code | LMD · Radiology |
| Decision Date | Sep 9, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2020 |
| Device Class | Class 1 |
| Attributes | Software as a Medical Device |
Intended Use
The intended use of this software package is to render 3-dimensional images from a series of Computer Tomography cross sectional images. The software is usable on either desktop or laptop standard PC" off-the-shelf" hardware configurations. The hardware (PC workstations) may be supplied by either the end-user or by Acculmage. 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.
Device Story
Software-based image processing workstation; runs on standard off-the-shelf PC hardware (desktop/laptop). Inputs: CT cross-sectional images (DICOM 3.0, ACR-NEMA 2.0, Imatron proprietary formats) via Ethernet or UPOW port from Imatron C100/C150 scanners. Processing: 3D rendering, window/level adjustment, false color, zoom, filtering (edge, sharpen, smooth), cine display, manual segmentation (contour drawing), CT-number thresholding, and volume rendering (MIP, MinIP, surface rendering, depth-encoded surface, quick MIP, sliding slab MIP). Outputs: 2D/3D images displayed on CRT or LCD monitors. Used by clinicians for diagnostic visualization of CT data. Benefits: enables 3D reconstruction and enhanced visualization of CT datasets to assist in clinical assessment.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Software-based image processing workstation; runs on Pentium-based PC hardware with Windows 95. Supports DICOM 3.0, ACR-NEMA 2.0, and Imatron proprietary formats. Connectivity via GPIB (IEEE488) or Ethernet. Display resolution up to 512x512, 12-bit depth. Storage via IDE disk drives.
Indications for Use
Indicated for rendering 3D images from CT cross-sectional image series for clinical visualization.
Regulatory Classification
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.
Predicate Devices
- Cemax VIPStation and/or Software (K945188)
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- K965179 — INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO · Neo Imagery Technologies, Inc. · Jul 3, 1997
- K032096 — PHILIPS VIEWFORUM 2003 · Philips Medical Systems · Jul 18, 2003
- K992654 — PLUG 'N VIEW 3D, VERSION 1.0 · Voxar Limited · Nov 5, 1999
