(120 days)
The CareView 1500Cw detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
CareView 1500Cw is a kind of wireless portable digital X-ray flat panel detectors which have 434mm×355mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally.
The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.
The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
The detector can't provide feedback to the generator to terminate the x-ray exposure.
The provided text describes a 510(k) premarket notification for the CareView 1500Cw X-ray Flat Panel Detectors. It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.
The document focuses on demonstrating substantial equivalence to a predicate device (ViVIX-S Wireless, K122865) based on:
- Technological Characteristics: Comparing specifications like image matrix size, pixel pitch, effective imaging area, grayscale, spatial resolution, etc.
- Nonclinical studies: Evaluation of parameters like Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF), noise power spectrum (NPS), spatial resolution, etc.
- Clinical considerations: A "concurrence study of 30 clinical images" comparing the proposed device to the predicate.
Therefore, I cannot provide the requested information for an AI/ML device as it is not present in the provided document. The device described is an X-ray flat panel detector, not an AI/ML-driven diagnostic tool.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.