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FDA-cleared K242166

TribusConnect

TribusMed Beheer BV

Authorized purpose: TribusConnect provides remote viewing and manipulation of CT DICOM data for pre- and post-cardiac-intervention review, including volume rendering, heart segmentation, simulated fluoroscopy, endoluminal views, MIP, and MPR; it is an adjunct and not diagnostic on mobile devices.

Modality
CT/CTA
Anatomy
Cardiac anatomy
Decision
2025-03-31