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

K203103

Fujifilm Corporation · cleared 2021-02-09 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Synapse 3D Base Tools is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning.”

AlgorithmSome segmentation applications are implemented using a deep learning method called as "Fully Convolutional Network". New segmentation features also use an algorithm “graph cuts”.

source quote (p.10)

“1. The new segmentation features implemented using an algorithm “graph cuts” same as the algorithm used in our previously cleared Synapse 3D Basic Tools (K120361). 2. The old segmentation features that had existed in our previously cleared Synapse 3D Basic Tools (K120361) are implemented using a new algorithm called as “Fully Convolutional Network" a new deep learning-based algorithm. 3. The new segmentation features are implemented using a new algorithm called as “Fully Convolutional Network" — a new deep learning-based algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.11)

“The confidentiality, integrity and availability are maintained by Synapse 3D Base Tools in accordance with Section 6 of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).”

Validation studies (1)

Bench

sample size not stated

endpoints: achieved the expected accuracy performance; Pass/Fail criteria were based on the requirements and intended use of the product

standards: Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 – 3.20) (2016)., AAMI / ANSI / IEC 62304:2015, Medical Device Software - Software Life Cycle Processes., ISO 14971 Second Edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K243762 (decision 2025-05-21) from FUJIFILM Corporation for a matching device line ("Synapse 3D Base Tools (V7.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243762
adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
…and 21 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).