← Product Code [LMD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD) · K961023 # AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) (K961023) _Accuimage, Inc. · LMD · Sep 9, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K961023 ## Device Facts - **Applicant:** Accuimage, Inc. - **Product Code:** [LMD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD.md) - **Decision Date:** Sep 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2020 - **Device Class:** Class 1 - **Review Panel:** Radiology - **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. ## Regulatory 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](/device/K945188.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SEP - 9 1996 K961023 # 510(k) SUMMARY ## 1.1 Company Identification Acculmage, Inc. 1849 Old Bayshore Blvd. Burlingame, CA 94010 (415) 692-8550 ## 1.2 Official Correspondent Gary J. Allsebrook Regulatory Affairs ## 1.3 Date of Submission March 12, 1996 ## 1.4 Device Name Classification Name: 90LLZ, System, Image Processing Common/Usual Name: Image Processing Workstation Proprietary Name: Acculmage, Inc. Image Display Processor ## 1.5 Substantial Equivalence Cemax VIPStation and/or Software K945188, 2-Aug.-95 ## 1.6 Device Description and 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 {1} K961023 connection or through the UPOW port of the Imatron C100 and C150 series of Ultrafast Electron Beam CT Scanners. ### 1.7 Software Development Acculmage certifies that the Image Display Processor software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used for camera control only and does not affect the image. ### 1.8 Substantial Equivalence Comparison Chart Comparison Table | Feature | AccuImage AIDP2.1 | Cemax VIP | | --- | --- | --- | | Network Connectivity | General Purpose Interface Protocol (GPIB IEEE488) | Ethernet (TCP/IP), MegaLink | | Computer Platform | Pentium/Win-95 | Sun Sparc/SunOS | | Image Format In | Imatron Proprietary ACR NEMA 2.0 DICOM 3.0 | Imatron Proprietary ACR NEMA 2.0 | | Image Format Out | BMP | TIFF | | Image Archive | IDE Disk drive, 1+ gig | SCSI Disk drive, 1+ gig | | Image Display | Color/greyscale, CRT or Laptop LCD Up to 512x512, 12-bits | Color/greyscale, CRT Up to 1024x1024,12 bits | | Image Processing | Window/level, false color Zoom, variable Filter: edge, sharpen, smooth Cine display | Same | | Image Edit | Manual segmentation by drawing a contour. Segmentation by CT-number threshold. | Same | | Volume Rendering | Max or Min Intensity Projection (MIP, MinIP) Surface rendered Depth encoded surface Quick Mip Sliding Slab MIP | Max. Intensity Projection (MIP) Surface rendered | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K961023](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K961023) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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