(59 days)
Imageshare 910TM, Imaging WorkbenchTM, FISSTM, RadWorksTM
Not Found
No
The description focuses on image acquisition, reformatting, and transmission, which are standard image processing and data handling tasks, not indicative of AI/ML. There is no mention of AI, ML, deep learning, or any related concepts.
No
The device primarily functions as a data acquisition and conversion system for medical images, facilitating the transfer of image files between different systems. It does not exert any direct therapeutic effect on a patient.
No
This device is described as a "uni-directional gateway" that receives and reformats images for transmission, essentially serving as a data conversion and transfer system. It does not perform analysis or interpretation of medical images to diagnose conditions.
No
The device description explicitly states "The Imageshare Secondary Capture Acquisition Station is a general purpose computer system running an image acquisition software application," indicating it includes hardware (a general purpose computer system) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "uni-directional gateway" for receiving, converting, and transmitting medical images. It focuses on data handling and format conversion, not on analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The device description reinforces this by explaining it's a "general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information." It's about managing image data flow.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results based on laboratory tests.
The device's function is related to medical imaging data management, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Imageshare Secondary Capture Acquisition Station and/or Software is a uni-directional gateway that receives digital or analog images from various image sources (including, but not limited to, film digitizers, video signal outputs or print output from imaging modalities, or other imaging sources). The incoming data formats are bitmapped, raster images or proprietary to the modality source vendor. The Imageshare Secondary Capture Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
Product codes
Not Found
Device Description
The Imageshare Secondary Capture Acquisition Station is a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a source (film digitizer, video source, ultrasound, print output, etc.) and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data and data entered by an operator through a user interface. The Imageshare Secondary Capture Acquisition Station stores the data on its local hard disk until the destination application acknowledges the successful transmission. Images not delivered to their destination are queved for retransmission until the remote destination confirms receipt of the message. Image delivery is also guaranteed when the Imageshare Secondary Capture Acquisition Station loses power and is restarted.
The Imageshare Secondary Capture Acquisition Station is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Secondary Capture Acquisition Station to perform functions specific to the site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
film digitizers, video signal outputs or print output from imaging modalities, or other imaging sources
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)
Imageshare 910TM, Imaging WorkbenchTM, FISSTM, RadWorksTM
Reference Device(s)
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
1. 510(k) Summary
NOV - 7 1996
510(k) Summary
[As required by 21 CFR 807.92(c)]
1.0 Submitter Information
| 1.1 | DeJarnette Research Systems
401 Washington Avenue Suite 700
Towson MD 21204 | 1.2 | Contact: | Wayne T. DeJarnette, Ph.D. |
|-----|-----------------------------------------------------------------------------------|-----|----------|----------------------------|
| | | | Voice: | +1 (410) 583 - 0680 |
| | | | Fax: | +1 (410) 583 - 0696 |
| | | | E-mail: | info@dejarnette.com |
1.3 Date Prepared: 6 Sept 1996
2.0 Device Identification
- 2.1 Trade Name: Imageshare Secondary Capture Acquisition Station and/or Software
- Common Name: 2.2 Gateway to Digital Imaging Network
- Classification Name: 2.3 System, Digital Image Communication, accessory
3.0 Predicate Devices
Imageshare 910TM (DeJarnette Research Systems, Inc.)
Imaging Workbench™ (BRIT Systems, Inc.)
FISSTM (Star Technologies, Inc.)
RadWorks™ (Applicare Medical Imaging B.V.)
4.0 Device Description
4.1 Function:
The Imageshare Secondary Capture Acquisition Station is a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a source (film digitizer, video source, ultrasound, print output, etc.) and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data and data entered by an operator through a user interface. The Imageshare Secondary Capture Acquisition Station stores the data on its local hard disk until the destination application acknowledges the successful transmission. Images not delivered to their destination are queved for retransmission until the remote destination confirms receipt of the message. Image delivery is also guaranteed when the Imageshare Secondary Capture Acquisition Station loses power and is restarted.
The Imageshare Secondary Capture Acquisition Station is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Secondary Capture Acquisition Station to perform functions specific to the site.
1
EJARNETTE
4.2 Physical and Performance Characteristics:
The Imageshare Secondary Capture Acquisition Station and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed, and finally the limitation of the image capture device. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
5.0 Intended Use:
The Imageshare Secondary Capture Acquisition Station and/or Software is a uni-directional gateway that receives digital or analog images from various image sources (including, but not limited to, film digitizers, video signal outputs or print output from imaging modalities, or other imaging sources). The incoming data formats are bitmapped, raster images or proprietary to the modality source vendor. The Imageshare Secondary Capture Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
6.0 Statement of Substantial Equivalence:
The Imageshare Secondary Capture Acquisition Station and/or Software is substantially equivalent to previously marketed devices (as listed above in Part 3) in design, composition. function, intended use, safety and efficacy.
Any differences between the Imageshare Secondary Capture Acquisition Station and/or Software and the predicate devices have no significant influence on safety or efficacy. No new issues of safety and effectiveness are raised.