Cleared Traditional

K120361 - SYNAPSE 3D BASE TOOLS

K120361 is an FDA 510(k) clearance for SYNAPSE 3D BASE TOOLS, manufactured by Fujifilm Medical Systems U.S.A, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K120361 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Apr 2012
Decision
60d
Days
Class 2
Risk

K120361 is an FDA 510(k) clearance for the SYNAPSE 3D BASE TOOLS. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Stamford, US). The FDA issued a Cleared decision on April 6, 2012 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Fujifilm Medical Systems U.S.A, Inc. devices

FDA 510(k) Submission Details - K120361

510(k) Number K120361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date April 06, 2012
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1882
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K120361.
ALPHAPOINT IMAGING SOFTWARE
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K120315 · Siemens Medical Solutions USA, Inc. · Apr 2012
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K120187 · Igt, LLC Dba Eigen · Apr 2012
THE DOME GX4MP COLOR NONITOR
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GE ECHOPAC
K120221 · Ge Healthcare · Mar 2012
VISIA ONCOLOGY
K120484 · Mevis Medical Solutions AG · Mar 2012