(57 days)
Imageshare 910, Fuji Computed Radiography DMS CRT Image Console HI-C654TM, CEMAX ScanLink IV QA Station, Analogic SD100 CR Gateway
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No
The description focuses on data acquisition, reformatting, and transmission, with no mention of AI/ML algorithms for image analysis or interpretation.
No
The device is described as a gateway and software that receives, converts, and transmits digital images, primarily for acquisition and routing of diagnostic images. There is no indication it treats or diagnoses any medical condition.
No
Explanation: The device is described as a "uni-directional gateway" that receives digital images, converts their format, and transmits them. Its function is to facilitate the routing and reformatting of image data, not to perform analysis or interpretation for diagnostic purposes.
Unknown
The description uses "Imageshare Computed Radiography Acquisition Station and/or Software," implying it could be either a hardware station with software or just the software. The device description mentions operating "on a general purpose computer system," which could be interpreted as the software running on existing hardware, but it also refers to "The Imageshare Computed Radiography Acquisition Station stores the data on its local-fard disk," suggesting a dedicated hardware component. Without further clarification, it's unclear if the submission covers only the software or a combined hardware/software system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the Imageshare Computed Radiography Acquisition Station and/or Software is a gateway for receiving, reformatting, and transmitting digital images from various imaging sources (like CR and DR devices). It deals with image data, not biological samples.
- Lack of mention of biological samples or analysis: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device's purpose is to manage and convert medical images for transmission, which falls under the category of medical imaging informatics or image management systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Imageshare Computed Radiography Acquisition Station and/or Software is a uni-directional gateway that receives digital images from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography 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
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Device Description
The Imageshare Computed Radiography Acquisition Station and/or Software is designed 1 operate on 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 Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered by an operator through a user interface. The Imageshare Computed Radiography Acquisition Station stores the data on its local-fard disk until the destination application acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Radiography (CR), Fuji HI-C654, Analogic Corporation's DASM, Direct Radiography
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)
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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.
Imageshare 910, Fuji Computed Radiography DMS CRT Image Console HI-C654TM, CEMAX ScanLink IV QA Station, Analogic SD100 CR Gateway
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
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§ 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
510(k) Summary
NOV -7 1996
K963628
[As required by 21 CFR 807.92(c)]
Submitter Information 1.0
- 1.1 DeJarnette Research Systems 401 Washington Avenue Suite 700 Towson MD 21204
- 1.2 Contact: Voice: Fax: E-mail:
Wayne T. DeJarnette, Ph.D. +1 (410) 583 - 0680 +1 (410) 583 - 0696 info@dejarnette.com
- 9 Sept 1996 1.3 Date Prepared:
Device Identification 2.0
- 2.1 Trade Name: Imageshare Computed Radiography Acquisition Station and/or Software
- 2.2 Common Name: Gateway to Digital Imaging Network
- System, Digital Image Communication, accessory 2.3 Classification Name:
3.0 Predicate Devices
Imageshare 910
Fuji Computed Radiography DMS CRT Image Console HI-C654TM
CEMAX ScanLink IV™ QA Station
Analogic SD100 CR Gateway
Device Description 4.0
4.1 Function:
The Imageshare Computed Radiography Acquisition Station and/or Software is designed 1 operate on 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 Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered by an operator through a user interface. The Imageshare Computed Radiography Acquisition Station stores the data on its local-fard disk until the destination application acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.
Physical and Performance Characteristics: 4.2
The Imageshare Computed Radiography 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. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
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5.0 Intended Use:
The Imageshare Computed Radiography Acquisition Station and/or Software is a uni-directional gateway that receives digital images from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography 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.
Statement of Substantial Equivalence: 6.0
The Imageshare Computed Radiography 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. No new issues of safety and effectiveness are raised.
Any differences between the Imageshare Computed Radiography Acquisition Station and the predicate devices have no significant influence on safety or efficacy.