(27 days)
The Xplorer 1500 Digital Radiographic System with stand (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting or standing. The Xplorer 1500 (510k submission device) is not intended for mammography.
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This is a letter about a 510(k) clearance for a digital radiographic system, which means it describes the regulatory approval of a medical device. It does not contain information about acceptance criteria or a study proving that the device meets them. There is no information in the document regarding:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, qualifications of experts, or adjudication method for any test set.
- Multi-reader multi-case comparative effectiveness studies or their effect sizes.
- Standalone (algorithm-only) performance studies.
- Types of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a notification of substantial equivalence for the "Xplorer 1500 Digital Radiographic System with Stand" to legally marketed predicate devices. It outlines the intended use of the device and its regulatory classification.
§ 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.