Synapse PACS (7.5)
K243647FUJIFILM Healthcare Americas Corporation · cleared 2025-06-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“As a Software as a Medical Device (SaMD), Synapse PACS performs these purposes without being part of a hardware medical device.”
AlgorithmAI algorithm
source quote (p.6)
“Bone removal is a tool that enhances the visibility of vessels in 3D rendered images by masking out bone regions. The tool is based on an AI algorithm cleared and marketed for Synapse 3D (K221677, reference device).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Bench
n=72 patients
endpoints: Dice Similarity Coefficient (DSC); 95% Hausdorff Distance (HD)
Reported performance (1 observation)
diceas written: “Dice Similarity Coefficient (DSC)”0.959CI [0.955 – 0.963]
source quote (p.6)
“The mean observed dice overlap coefficient and 95% HD with 95% confidence intervals were 0.959 [0.955 – 0.963] and 1.367 mm [1.170 mm – 1.563 mm], respectively, exceeding the predefined acceptance thresholds.”
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). 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).