Synapse 3D Base Tools (V7.0)

K243762

FUJIFILM Corporation · cleared 2025-05-21 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The 3D image analysis software Synapse 3D Base Tools (V7.0) is medical application software running on Windows server/client configuration installed on commercial general-purpose Windows-compatible computers. It offers software tools which can be used by trained professionals to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans. Some new segmentation applications are added and implemented using the same deep learning method called as "Fully Convolutional Network".”
Algorithmdeep learning method called as "Fully Convolutional Network"
source quote (p.10)
“Some new segmentation applications are added and implemented using the same deep learning method called as "Fully Convolutional Network".”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.17)
“The confidentiality, integrity and availability are maintained by Synapse 3D Base Tools in accordance with Section IV (B.) of the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (April 8, 2022). Synapse 3D Base Tools is connected through DICOM standard to medical devices and to a PACS system storing data generated by these medical devices, and it retrieves image data via network communication based on the DICOM standard. Therefore Synapse 3D Base Tools assures an adequate degree of protection for cybersecurity.”

Validation studies (1)

Retrospective clinical

n=1,086 cases · 5 site(s)

standards: Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 – 3.20) (2016), IEC 62304 Edition 1.1 2015-06, Medical Device Software - Software Life Cycle Processes, ISO 14971:2019 2019-12-10, Medical Devices - Application of Risk Management to Medical Devices

Reported performance (3 observations)

diceas written: “DICE (Average) for Duodenum (CT)”0.85
source quote (p.15)
“Duodenum (CT) 30 0.85”
diceas written: “DICE (Average) for Pancreas section (Tail) (CT)”0.99
source quote (p.15)
“Pancreas section (Tail) (CT) 29 0.99”
diceas written: “DICE (Average) for Ureter (T2) (MRI)”0.63
source quote (p.16)
“Ureter (T2) (MRI) 33 0.63”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243762