(86 days)
The Imageshare Computed Radiography Acquisition Station and/or Software is a bi-directional gateway that sends or receives digital images to/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.
The Imageshare Computed Radiography Acquisition and/or Software is designed to 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 or configured by an operator through a user interface. The Imageshare Computed Radiography Acquisition stores the data on its local hard disk until the destination acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the "Imageshare Computed Radiography Acquisition Station and/or Software." It describes the device's function, intended use, and states its substantial equivalence to a predicate device.
Specifically, the document states:
- No acceptance criteria or device performance table: This information is completely absent from the provided text.
- No study details: There is no mention of any study conducted to assess the device's performance, meeting of acceptance criteria, or any of the other requested details (sample sizes, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details).
- No ground truth type: Because no study is described, there's no mention of the type of ground truth used.
The focus of this 510(k) summary is on establishing substantial equivalence to a previously marketed device based on design, composition, function, intended use, safety, and efficacy, rather than presenting a detailed performance study with acceptance criteria.
§ 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.