FDA-cleared K254075

Synapse Lung Nodule AI

Fujifilm Corporation

Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.

Modality
CT/CTA
Anatomy
Chest/lungs; pulmonary nodules
Decision
2026-05-27
FDA-cleared K254189

Synapse 3D Base Tools (V7.2)

Fujifilm Corporation

Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body and modality-specific anatomy represented in CT, MR, CR, US, NM, PT, and XA studies
Decision
2026-04-30
FDA-cleared K251386

ECHELON Synergy

Fujifilm Corporation

ECHELON Synergy is a whole-body MRI system that provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved...

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2025-09-17
FDA-cleared K243762

Synapse 3D Base Tools (V7.0)

FUJIFILM Corporation

Synapse 3D Base Tools assists trained professionals with reading, interpreting, reporting, and treatment planning from DICOM data from CT, MR, CR, US, NM, PT, XA, and other...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in CT, MR, CR, US, NM, PT, and XA studies
Decision
2025-05-21
FDA-cleared K250370

SCENARIA View Phase 5.0

FUJIFILM Corporation

SCENARIA View acquires axial, helical, dynamic, and interventional CT images of the body, including the head and whole body, supports reformats and volume rendering, and includes...

Modality
CT/CTA
Anatomy
Whole body, head, thorax, and lungs
Decision
2025-05-20
FDA-cleared K203103

Synapse 3D, Synapse 3D Base Tools v6.1

Fujifilm Corporation

Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient anatomy represented in supported DICOM CT, MR, CR, US, NM, PT, and XA images; mammography excluded
Decision
2021-02-09