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510(k) Data Aggregation
(83 days)
XRT 600 R/F, WRF 0600
The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.
The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.
The provided text is a 510(k) K992603 clearance letter for the Wuestec XRT 600 R/F device, along with its "Indications For Use" statement.
This documentation does not contain any information regarding acceptance criteria, device performance metrics, or study design details. It is a regulatory approval document that states the device has been found substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given input.
To answer your request, I would need a document such as:
- A premarket submission summary.
- A clinical study report.
- A scientific publication detailing the device's performance evaluation.
The current document only confirms the FDA's regulatory clearance for the device, not the technical or clinical performance data.
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