Home » FDA Clears Up Performance Standards for Fluoroscopic Equipment
FDA Clears Up Performance Standards for Fluoroscopic Equipment
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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