Synapse MPR Fusion

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K113244 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Fujifilm Medical System U.S.A., Inc. →

• What is the Synapse MPR Fusion software designed for?

  The Synapse MPR Fusion is a software application designed to integrate with Picture Archiving and Communication Systems (PACS) environments. It enables radiologists to display, compare, and fuse three-dimensional (3D) medical images from modalities like CT, MR, PET, and SPECT. This enhances diagnostic accuracy by providing advanced visualization techniques such as Maximum Intensity Projection (MIP) and Multiplanar Reconstruction (MPR), improving workflow efficiency in radiology settings.

• How is the Synapse MPR Fusion supplied and what are its system requirements?

  The Synapse MPR Fusion is supplied as a software solution intended for integration into existing PACS infrastructure. It requires a compatible IT environment to operate, meaning it must be installed on systems that meet the manufacturer’s technical specifications for PACS compatibility. The device is not standalone hardware but relies on the underlying PACS platform for functionality.

• Is the Synapse MPR Fusion classified as single-use or reusable?

  The Synapse MPR Fusion is not described as single-use or reusable in the available data. As a software application, its usability depends on the underlying IT infrastructure and PACS system, which are typically maintained and reused for ongoing diagnostic purposes. There are no indications of sterility or physical reuse requirements since it operates digitally.

• What regulatory pathway was followed for FDA clearance of the Synapse MPR Fusion?

  The Synapse MPR Fusion was cleared by the FDA under the Special 510(k) pathway, which allows for a 50-day review process. It is classified as a Class 2 Radiology device under product code LLZ, with a decision description indicating it is substantially equivalent to a predicate device. The clearance was granted following a review by the Radiology (RA) advisory committee.

• Can the Synapse MPR Fusion be used with any imaging modality, or are there specific limitations?

  The Synapse MPR Fusion is designed to work with multiple imaging modalities, including CT, MR, PET, and SPECT. However, its functionality depends on the compatibility of the source images with the software’s algorithms for fusion and reconstruction. Users should ensure their imaging systems generate data formats that the software can process for accurate visualization and diagnostic use.