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FDA-cleared K180589

DR 800 with MUSICA Dynamic

Agfa HealthCare N.V.

Authorized purpose: DR 800 with MUSICA Dynamic is a digital radiography and dynamic-fluoroscopy system for routine radiography, positioning, gastrointestinal, urogenital, angiographic, and pediatric examinations across the labeled body regions; it is not a mammography system.

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2018-04-05