(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.
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SEP - 9 1996
K961023
510(k) SUMMARY
1.1 Company Identification
Acculmage, Inc. 1849 Old Bayshore Blvd. Burlingame, CA 94010 (415) 692-8550
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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 |
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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
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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 InterfaceProtocol (GPIB IEEE488) | Ethernet (TCP/IP),MegaLink |
| Computer Platform | Pentium/Win-95 | Sun Sparc/SunOS |
| Image Format In | Imatron ProprietaryACR NEMA 2.0DICOM 3.0 | Imatron ProprietaryACR 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 orLaptop LCDUp to 512x512, 12-bits | Color/greyscale, CRTUp to 1024x1024,12 bits |
| Image Processing | Window/level, false colorZoom, variableFilter: edge, sharpen,smoothCine display | Same |
| Image Edit | Manual segmentation bydrawing a contour.Segmentation by CT-number threshold. | Same |
| Volume Rendering | Max or Min IntensityProjection (MIP, MinIP)Surface renderedDepth encoded surfaceQuick MipSliding Slab MIP | Max. Intensity Projection(MIP)Surface rendered |
Comparison Table
§ 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.