(64 days)
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No
The summary describes a basic picture archiving and communications system (PACS) with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The software runs on Windows 95, which is an older operating system not typically associated with modern AI/ML implementations.
No
The device is described as a picture archiving and communications system for colposcopy procedures. It displays, processes, digitizes, stores, and transmits images. There is no indication that it provides any direct treatment or therapy to a patient.
No
The device is described as a picture archiving and communications system, which displays, processes, stores, and transmits images. It does not perform analysis or provide interpretations for diagnostic purposes.
No
The device description explicitly states that hardware components are purchased from other manufacturers and that the system includes both hardware and software components for image processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a picture archiving and communications system during colposcopy procedures." This describes a system for managing images, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the device being a "picture archiving and communications system" and its hardware/software components.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. IVDs are specifically designed for testing samples taken from the body.
- Image Processing: While the device processes images, this is within the context of managing visual data from a procedure, not analyzing biological samples for diagnostic markers.
The device functions as a tool to support a medical procedure (colposcopy) by managing the images generated during that procedure. This falls under the category of medical imaging systems or PACS (Picture Archiving and Communication Systems), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format.
Mentions image processing
The DIMS device can display, process, digitize, store, and transmit images obtained during colposcopy examinations using hardware and software components.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software testing was conducted as part of the development process.
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
(520) 889-7900 (520) 741-2200 Fax:
MAY -8 1997
510(k) SUMMARY
DenVu L.C. Submitter's name:
Date summary prepared:
February 24, 1997
Device name:
DENVU L.C.
Tucson. AZ 85714
4400 South Santa Rita Avenue
Proprietary name:
Common or usual name:
Classification name:
DIMS (Digital Imaging and Medical System), Model CL1-5110 and Model CL1-5111. Picture archiving and communications system (PACS). Proposed classification: Picture archiving and communications systems (PACS), Class II, 21 CFR 892.2050.
Legally marketed device for substantial equivalence comparison:
Wallach Digital Imaging System submitted by Wallach Surgical Devices, Inc. and cleared for marketing under 510(k) "K950630.
Description of the device:
The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format.
Intended use of device:
The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures.
Technological characteristics:
The DIMS device can display, process, digitize, store, and transmit images obtained during colposcopy examinations using hardware and software components.
Testing conducted:
Software testing was conducted as part of the development process.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).