(57 days)
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.
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.
This 510(k) summary does not contain the information needed to answer your questions regarding acceptance criteria and study details. The document describes the "Imageshare Computed Radiography Acquisition Station and/or Software" as a gateway for digital images, converting formats and transmitting data. It focuses on the device's function, intended use, and claims substantial equivalence to previously marketed devices.
Specifically, the document does not include:
- Acceptance criteria or device performance data.
- Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC, or standalone performance).
- Training set information.
The document is purely descriptive of the device's functionality and its claim of substantial equivalence to predicate devices, without presenting any pre-market clinical or performance evaluations in the way you've described.
§ 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.