Cleared Traditional

K183248 - Synapse Enterprise Viewer Version 1.0

K183248 is the FDA 510(k) clearance for Synapse Enterprise Viewer Version 1.0 by Fujifilm Corporation. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K183248 · Fujifilm Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
155d
Days
Class 2
Risk

K183248 is an FDA 510(k) clearance for the Synapse Enterprise Viewer Version 1.0. 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, Tokyo, JP). The FDA issued a Cleared decision on April 25, 2019 after a review of 155 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 K183248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2018
Decision Date April 25, 2019
Days to Decision 155 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
48d slower than avg
Panel avg: 107d · This submission: 155d
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 Medical Systems U.S.A, Inc.
Jeffrey Naveda

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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1096
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K183248.
syngo.via (Version VB40A)
K191040 · Siemens Healthcare GmbH · May 2019
SurgicalAR
K190764 · Medivis, Inc. · May 2019
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
K190866 · Rayence Co., Ltd. · Apr 2019
Brainlab Elements Image Fusion Angio
K190042 · Brainlab AG · Apr 2019
Ez3D-i/E3
K190791 · Ewoosoft Co., Ltd. · Apr 2019
Lung Vision System
K183593 · Bodyvision Medical , Ltd. · Apr 2019