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BrightMatter Plan 1.6.0

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180394

by Synaptive Medical Inc

Identifiers

510(k) Number
K180394 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BrightMatter Plan 1.6.0 is a System, Image Processing, Radiological device designed for use in radiology. It functions as a software-based planning platform for image-guided interventions, enabling precise visualization and planning of medical procedures using radiological imaging data.

This device is supplied as a software application for use on compatible hardware platforms, requiring no physical sterilization. It is intended for single-use sessions within MRI-safe environments, adhering to regulatory standards under the FDA’s 510(k) clearance (K180394). No specific size or storage requirements are noted beyond standard IT infrastructure, and its use is governed by the Radiology Advisory Committee under classification LLZ.

Frequently asked questions

What type of medical procedures can the BrightMatter Plan 1.6.0 software assist with, and how does it work?

The BrightMatter Plan 1.6.0 is a software-based planning platform designed specifically for image-guided interventions in radiology. It uses radiological imaging data to provide precise visualization and planning tools, helping clinicians prepare for procedures like biopsies, ablations, or other minimally invasive interventions that require careful targeting within MRI-safe environments.

Is the BrightMatter Plan 1.6.0 meant for reuse across multiple patients, or is it intended for single-use sessions?

The BrightMatter Plan 1.6.0 is intended for single-use sessions. While it is a software application and not a physical device requiring sterilization, each planning session is treated as a distinct use case, ensuring data integrity and patient safety in radiology workflows.

What hardware requirements or infrastructure does the BrightMatter Plan 1.6.0 need to operate, and how is it supplied?

The BrightMatter Plan 1.6.0 is supplied as a software application and requires compatible hardware platforms to run. Since it is not a physical device, there are no specific size or storage requirements beyond standard IT infrastructure, such as a computer system meeting the software’s technical specifications for radiology planning.

How is the regulatory approval for the BrightMatter Plan 1.6.0 structured, and which committee oversees its classification?

The BrightMatter Plan 1.6.0 received FDA clearance under the 510(k) pathway (K180394) and is classified under the Radiology Advisory Committee (RA) with the product code LLZ. The device was determined to be substantially equivalent to a predicate, following a traditional review process, ensuring compliance with radiological planning standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Synaptive BrightMatter Plan 1.6.0 - allmed.wiki, BrightMatter Plan 1.6.0 510(k) K180394 - FDA.report, FDA 510 (k), K180394, BrightMatter Plan 1.6.0 - foiadocs.com, PDF K180394 - BrightMatter Plan 1

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Synaptive Medical Inc
FDA Applicant
Synaptive Medical, Inc.

Sources (1)

  • FDA 510(k) K180394 24 fields · synced Sep 19, 2026