(12 days)
The GE Tethered Portable Digital Radiographic Detector is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammograpohic applications.
The GE Tethered Portable Digital Radiographic Detector is a digital X-Ray detector comprised of amorphous silicon with a cesium iodide scintillator that has been repackaged for mobile and portable use, and may be used as a film cassette replacement in portable radioraly unis.
The provided text for the GE Tethered Portable Digital Radiographic Detector states "Clinical Tests: None required." The summary indicates that the device's intended uses and features are consistent with traditional clinical practice, FDA guidelines, and established methods. It also mentions that the fundamental scientific technology is the same as the legally marketed GE Digital Radiographic Imaging System (K982196). The device underwent evaluation for electrical and radiation safety and conforms with applicable medical device safety standards.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance.
- Whether a standalone (algorithm only without human-in-the-loop performance) study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.