(152 days)
This device is intended for use in generating radiographic images of neonatal anatomy. It is intended to replace radiographic film/ screen or CR systems in neonatal general-purpose diagnostic procedures. This device is not intended for mammography applications.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the Pvmed ddr 2430t. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily focuses on:
- The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
- Information related to regulatory compliance for the device.
- Indications for Use: Generating radiographic images of neonatal anatomy, replacing film/screen or CR systems in neonatal general-purpose diagnostic procedures, and specifically stating it is not for mammography applications.
Therefore, I cannot fulfill your request for a table of acceptance criteria and the study details as this information is not present in the provided text.
§ 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.