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Guidance for Industry and FDA Staff – Diagnostic X-Ray, Ultrasound Systems and Laser Equipment

21 February 2023 – the FDA published final guidance documents on diagnostic x-ray, ultrasound systems and laser equipment.

Assembler’s Guide to Diagnostic X-Ray Equipment  
Performance Standard for Diagnostic X-Ray Systems and Their Major Components 
Laser Products-Conformance (Laser Notice No. 56) 
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers 
Medical X-Ray Imaging Devices Conformance with IEC Standards 
Premarket Notification Submissions for Ultrasonic Diathermy Devices 
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