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FDA-cleared K261713

Synapse PACS (7.6.0)

FUJIFILM Healthcare Americas Corporation

Synapse PACS 7.6.0 provides medical-image management and processing, including measurements, regional segmentation, clinical calculations, structured reports, comparison, fusion, and volume rendering to aid reading, interpretation, reporting, and treatment planning.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2026-06-18
FDA-cleared K243647

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Authorized purpose: Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting, integrated 3D, two-point VOI, and AI-assisted bone removal.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2025-06-30
FDA-cleared K233687

ECHELON Synergy V10.0

Fujifilm Healthcare Americas Corporation

Authorized purpose: ECHELON Synergy V10.0 is a magnetic-resonance diagnostic system that provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, and extremities for trained physician interpretation.

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2024-05-03