(28 days)
The Xplorer 1600 Plus is intended for use by a qualified/trained doctor or technologist on both adult and pediatric palients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
The Xplorer 1600 Plus (510k submission device) is not intended for mammography.
Xplorer 1600 Plus digital radiographic system
This document is a 510(k) clearance letter from the FDA for a medical device called the "Xplorer 1600 Plus Digital Radiographic System." It does not contain sections on acceptance criteria or detailed study information typically found in a clinical study report. Therefore, I cannot extract the requested information from the provided text.
Specifically, the document:
- Identifies the device: Xplorer 1600 Plus Digital Radiographic System.
- States its intended use: Taking diagnostic radiographic exposures of various body parts in adult and pediatric patients (excluding mammography).
- Confirms regulatory clearance: Substantial equivalence to a legally marketed predicate device.
- Outlines general regulatory requirements.
This type of FDA letter confirms market clearance based on substantial equivalence to an existing device, rather than providing the detailed performance studies and acceptance criteria that you've asked for. Such information would typically be found in the 510(k) submission itself or a separate scientific report.
§ 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.