(179 days)
Not Found
No
The description focuses on standard 3D rendering of CT images and data format compatibility, with no mention of AI or ML techniques.
No
The device is described as software that renders 3D images from CT scans. It is used to process and display digital image data, which is a diagnostic function, not a therapeutic one.
No
The software renders 3D images from CT scans. It is an image processing and visualization tool, not a diagnostic device that interprets or analyzes medical conditions. Its output is for viewing, not for making a diagnosis.
Yes
The device description explicitly states "The Acculmage software processes and displays digital image data". While it mentions input methods (Ethernet, UPOW port) and compatibility with specific CT scanners, the core device being described and cleared is the software package itself, which performs the image processing and display function. The hardware components (CT scanners, computers for display) are external to the cleared device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "render 3-dimensional images from a series of Computer Tomography cross sectional images." This describes image processing and visualization, not the analysis of biological samples or the diagnosis of diseases based on in vitro tests.
- Device Description: The description focuses on processing and displaying digital image data from CT scanners. This aligns with medical imaging software, not IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
The device is clearly described as software for processing and displaying medical images obtained from a CT scanner. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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-theshelf" 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.
Product codes
90LLZ
Device Description
The Acculmage, Inc. Image Display Processor is a software package designed to render 3-dimensional images from a series of Computer Tomography cross-sectional images. It is compatible with standard PC hardware configurations (desktop or laptop) and can be supplied by the end-user or Acculmage. The software processes and displays digital image data in DICOM 3.0, ACR-NEMA 2.0, or Imatron Proprietary format. It supports data input via standard Ethernet connection or through the UPOW port of Imatron C100 and C150 series Ultrafast Electron Beam CT Scanners. Features include network connectivity (GPIB IEEE488), compatibility with Pentium/Win-95 platforms, image output in BMP format, image archiving on IDE disk drives, color/greyscale display up to 512x512 with 12-bits, image processing (window/level, false color, zoom, variable, filter: edge, sharpen, smooth, Cine display), image editing (manual segmentation by drawing a contour, segmentation by CT-number threshold), and volume rendering (Max or Min Intensity Projection (MIP, MinIP), Surface rendered, Depth encoded surface, Quick Mip, Sliding Slab MIP).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computer Tomography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
K945188, 2-Aug .- 95 Cemax VIPStation and/or Software -
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-theshelf" 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
connection or through the UPOW port of the Imatron C100 and C150 series of Ultrafast Electron Beam CT Scanners.
1.7 Software Development
Acculmage cortifies that the Image Display Processor software is developed, tested and validated according to written designed, 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
| 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 |
Comparison Table