IRISeg
K251763Intuitive Surgical, Inc. · cleared 2025-12-16 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“IRISeg is a standalone software application created by Intuitive Surgical for segmentation of CT and MR images and generation of output files that can be rendered as virtual 3D models of anatomical structures.”
Algorithmneural network based ML algorithm
source quote (p.6)
“The auto-segmentation algorithm is a neural network based ML algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“The cybersecurity verification and validation testing were conducted, and cybersecurity was evaluated per FDA’s Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (June 27, 2025).”
Validation studies (1)
Bench
sample size not stated
standards: ISO 14971, AAMI CR34971, IEC 62304
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
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).