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FDA-cleared K243005

AudaxCeph Cephalogram Analysis Software

Audax d.o.o.

Authorized purpose: AudaxCeph Cephalogram Analysis Software assists specialized dental practices with storing and presenting patient cephalogram images and treatment planning through landmark digitization, tracing, measurements, superimpositions, and visual treatment objectives; trained and licensed practitioners remain responsible for interpretation.

Modality
X-ray/Radiography
Anatomy
Dental/maxilla/mandible
Decision
2025-05-30