FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Clears Up Performance Standards for Fluoroscopic Equipment

May 9, 2019
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The FDA issued final guidance clarifying the performance standard requirements for certain fluoroscopic equipment, devices that use X-rays to capture real-time moving images of an object’s interior.

The agency decided to offer more clarification on fluoroscopy equipment performance standards based on input from a public meeting on reducing unnecessary radiation exposure from medical imaging.

The guidance doesn’t cover angiographic X-ray systems, as they are incapable of performing fluoroscopies.

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