510(k) · Radiology

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

by Fujifilm Corporation

Synapse 3D, Synapse 3D Base Tools v6.1 is an AI-enabled medical device from Fujifilm Corporation that the U.S. FDA cleared through 510(k) K203103 on February 9, 2021. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK203103
Pathway510(k)
Date of final decision
Company (FDA list)Fujifilm Corporation
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Fujifilm Corporation
Applicant locationTokyo, JP
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Synapse 3D, Synapse 3D Base Tools v6.1 went through this pathway (K203103).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #91 of 161 under that code. Fujifilm Corporation has 7 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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