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Synapse 3D Brain Perfusion

by Fujifilm Medical System U.S.A., Inc.

510(k) K120637

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120637 Date8 May 2012ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synapse 3D Brain Perfusion is a medical imaging software system designed for advanced analysis of cerebral perfusion using magnetic resonance (MR) dynamic scan images. It quantifies key perfusion parameters, including cerebral blood volume (CBV), cerebral blood flow (CBF), mean transit time (MTT), and time to peak (TTP), to assess blood flow dynamics in the brain. This tool supports diagnostic evaluation in neurological conditions by providing objective, quantitative measurements derived from perfusion imaging data. Its functionality aligns with perfusion imaging modalities, enabling clinicians to derive actionable insights from MR scans.

The device operates as a software solution integrated into imaging workflows, requiring compatibility with MR systems capable of dynamic perfusion imaging. It is supplied as a standalone application or as part of a broader imaging platform, with no indication of sterility or single-use/reusable classification. The system is intended for use in radiology departments or neuroimaging centers equipped with MRI technology. No specific regulatory approvals beyond the FDA 510(k) clearance (K120637) are stated, and its MRI safety classification or storage requirements are not detailed in the provided data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Synapse 3D Brain Perfusion software used for?

    The Synapse 3D Brain Perfusion software is designed to analyze cerebral perfusion using dynamic magnetic resonance (MR) imaging scans. It quantifies key perfusion parameters—cerebral blood volume (CBV), cerebral blood flow (CBF), mean transit time (MTT), and time to peak (TTP)—to evaluate blood flow dynamics in the brain. This helps clinicians assess neurological conditions by providing objective, quantitative insights derived from perfusion imaging data.

  • How is the Synapse 3D Brain Perfusion software supplied?

    The software is supplied as a standalone application or integrated into broader imaging platforms. It is not a physical device, so there are no sterility or single-use/reusable classifications. Compatibility with MR systems capable of dynamic perfusion imaging is required for proper functionality.

  • Is the Synapse 3D Brain Perfusion software intended for use in specific clinical settings?

    Yes, this software is intended for use in radiology departments or neuroimaging centers equipped with MRI technology. It is designed to integrate into existing imaging workflows where perfusion analysis is conducted, enabling clinicians to derive actionable diagnostic information from MR scans.

  • Does the Synapse 3D Brain Perfusion software have any regulatory approvals?

    The Synapse 3D Brain Perfusion software holds an FDA 510(k) clearance under the reference number K120637. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device. No additional regulatory approvals beyond this are explicitly stated in the provided data.

  • What types of MR systems is the Synapse 3D Brain Perfusion software compatible with?

    The software requires compatibility with MR systems that are capable of performing dynamic perfusion imaging. While the exact models or manufacturers are not specified, the system is designed to integrate seamlessly into radiology workflows where perfusion imaging is conducted, ensuring accurate quantification of cerebral perfusion parameters.