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The LaVid FMTS System is a stationery X-ray system intended for obtaining radiographic images of various of the human body, both pediatrics and adults, in a clinical environment.

The LaVid FMTS System is not intended for mammography, interventional, or fluoroscopy use.

The LaVid FMTS System is a stationery X-ray system intended for obtaining radiographic images of various of the human body, both pediatrics and adults, in a clinical environment.

This document is an FDA 510(k) clearance letter for the LaVid FMTS DIAGNOSTIC X-RAY SYSTEM. It indicates that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory provisions. However, the provided text does not contain information regarding:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Reported device performance metrics.
• Sample sizes used for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Effect size of human reader improvement with AI.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance for the device, its indications for use, and general regulatory compliance information. It does not delve into the technical performance evaluation that would typically include the requested details.

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