Cleared Traditional

K103465 - SYNAPSE 3D CARDIAC TOOLS

K103465 is the FDA 510(k) clearance for SYNAPSE 3D CARDIAC TOOLS by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K103465 · Fujifilm Medical Systems U.S.A, Inc. · Radiology device
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Jan 2011
Decision
68d
Days
Class 2
Risk

K103465 is an FDA 510(k) clearance for the SYNAPSE 3D CARDIAC 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 January 31, 2011 after a review of 68 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

Submission Details

510(k) Number K103465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date January 31, 2011
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
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 Peers - LLZ System, Image Processing, Radiological

All 1127
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