FDA-cleared K253690

LungMaps

Siemens Healthineers AG

LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.

Modality
MRI
Anatomy
Chest/Lung
Decision
2026-06-15
FDA-cleared K253023

BIOGRAPH One

Siemens Healthineers AG

BIOGRAPH One with syngo MR XB10 combines metabolic or physiologic PET information with MR anatomy, MR-based attenuation correction, fused alignment, and support for treatment...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2026-01-15
FDA-cleared K251059

Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole spine and other clinical image regions represented in supported CT and MR workflows
Decision
2025-10-24