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FDA-cleared K181892

Ziostation2

Ziosoft, Inc.

Authorized purpose: Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with release-specific tools for lung and bronchoscopy planning, cardiac MR T1 mapping, and other advanced visualization.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2018-10-09