IRISeg

K251763

Intuitive 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. IRISeg is designed to provide qualified professionals ("users") with a machine learning (ML)-based tool for auto-segmentation of kidney anatomy based on CT scans and non-ML manual tools for segmentation based on CT and MR scans.”
Algorithmneural network based ML algorithm
source quote (p.6)
“The auto-segmentation algorithm is a neural network based ML algorithm.”
Adaptive (vs locked)No
source quote (p.9)
“The algorithm was not modified in the subject device, and therefore the performance of the ML algorithm is as effective as in the predicate device.”
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“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 (0)

FDA source did not describe a validation study.

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); 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/K251763