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.