(59 days)
Imageshare 910, Merge MVP
Not Found
No
The description focuses on protocol conversion and data routing, with no mention of AI/ML techniques for image analysis or decision-making.
No.
The device's function is to convert and transmit digital image data between different formats and systems, not to directly treat or diagnose medical conditions.
No
The device is described as a gateway that converts and transmits digital images; it does not perform any analysis, interpretation, or diagnosis of the images.
No
The device description explicitly states it is a "general purpose computer system running a protocol conversion software application," indicating it includes hardware (the 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 is to receive, convert, and transmit digital images from various medical imaging sources. This is a data handling and communication function, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a computer system running protocol conversion software. Its function is to reformat and transmit image and demographic information. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting specific analytes, or providing results that are used for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device acts as a gateway for medical images, facilitating their transfer and compatibility between different systems. This is a crucial function in medical imaging workflows, but it does not fall under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Imageshare Protocol Converting Gateway and/or Software is a uni-directional (or optionally, bi-directional) gateway that receives digital images from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, or other imaging sources), The incoming data formats are DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Imageshare Protocol Converting Gateway converts them into DICOM, ACR-NEMA v2.0, SPI format or 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 Protocol Converting Gateway is a general purpose computer system running a protocol conversion software application that uses defined configuration to receive, reformat and transmit image and demographic information. The system receives the image messages from a source and routes them automatically them through a conversion to a remote destination based on information contained in both the message source and encoded data. The system requires no user interaction when in operation. The Imageshare Protocol Converting Gateway stores the image data on its local hard disk until the destination application acknowledges the successful transmission. Images that are not delivered to their destination are queued for retransmission until the remote destination confirms receiving the message. This is also true when the Imageshare Protocol Converting Gateway loses power and is restarted.
The Imageshare Protocol Converting Gateway is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Protocol Converting Gateway to perform the desired supported conversions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, 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
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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 910 (DeJarnette Research Systems, Inc.), Merge MVP (Merge Technologies, Inc.)
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 K963592
NOV - 7 1996
510(k) Summary
[As required by 21 CFR 807.92(c)]
Submitter Information 1.0
| 1.1 | DeJarnette Research Systems | 1.2 | Contact: | Wayne T. DeJarnette, Ph.D. |
|---|---|---|---|---|
| 401 Washington Avenue Suite 700 | Voice: | +1 (410) 583 - 0680 | ||
| Towson MD 21204 | Fax: | +1 (410) 583 - 0696 | ||
| E-mail: | info@dejarnette.com |
- 6 September 1996 1.3 Date Prepared:
2.0 Device Identification
- 2.1 Trade Name: Imageshare Protocol Converting Gateway and/or Software
- 2.2 Common Name: Gateway to Digital Imaging Network
- 2.3 Classification Name: System, Digital Image Communication, accessory
Predicate Devices 3.0
Imageshare 910 (DeJarnette Research Systems, Inc.)
Merge MVP (Merge Technologies, Inc.)
4.0 Device Description
- 4.1 Function:
The Imageshare Protocol Converting Gateway is a general purpose computer system running a protocol conversion software application that uses defined configuration to receive, reformat and transmit image and demographic information. The system receives the image messages from a source and routes them automatically them through a conversion to a remote destination based on information contained in both the message source and encoded data. The system requires no user interaction when in operation. The Imageshare Protocol Converting Gateway stores the image data on its local hard disk until the destination application acknowledges the successful transmission. Images that are not delivered to their destination are queued for retransmission until the remote destination confirms receiving the message. This is also true when the Imageshare Protocol Converting Gateway loses power and is restarted.
The Imageshare Protocol Converting Gateway is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Protocol Converting Gateway to perform the desired supported conversions.
1-1
1
EJARNET
- Physical and Performance Characteristics: 4.2
The Imageshare Protocol Converting Gateway is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portabilily 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. 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 Protocol Converting Gateway and/or Software is a uni-directional (or optionally, bi-directional) gateway that receives digital images from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, or other imaging sources), The incoming data formats are DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Imageshare Protocol Converting Gateway converts them into DICOM, ACR-NEMA v2.0, SPI format or 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 Protocol Converting Gateway 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 Protocol Converting Gateway and/or Software and the predicate devices have no significant influence on safety or efficacy.