Cleared Traditional

K221677 - Synapse 3D Base Tools v6.6

K221677 is the FDA 510(k) clearance for Synapse 3D Base Tools v6.6 by Fujifilm Corporation. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K221677 · Fujifilm Corporation · Radiology device
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Nov 2022
Decision
154d
Days
Class 2
Risk

K221677 is an FDA 510(k) clearance for the Synapse 3D Base Tools v6.6. 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 Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on November 10, 2022 after a review of 154 days - an extended review 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 Corporation devices

Submission Details

510(k) Number K221677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2022
Decision Date November 10, 2022
Days to Decision 154 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 slower than avg
Panel avg: 107d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

FUJIFILM Healthcare Americas Corporation
Jeffrey Wan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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