IRISeg

K242461

Intuitive Surgical Inc. · cleared 2024-12-10 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“IRISeg Version 3.1 (“IRISeg”) is a standalone software application created by Intuitive Surgical for segmentation of contrast-enhanced kidney CT images and generation of output files that can be rendered as virtual 3D models of kidney organs. IRISeg is designed to provide qualified professionals ("users") with manual and machine learning (ML)-based tools for segmentation of kidney anatomy based on CT scans.”
Algorithmneural network based ML algorithm
source quote (p.6)
“IRISeg includes an ML-based auto-segmentation algorithm for automatic segmentation of four kidney structures from CT imaging. The auto-segmentation algorithm is a neural network based ML algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
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" (September, 2023). Specifically, addressing the following cybersecurity testing areas: security requirement testing, threat mitigation testing, vulnerability testing, and penetration testing. The cybersecurity verification and validation test results demonstrate the adequacy of the implemented cybersecurity controls.”

Validation studies (1)

Bench

n=81 scans

endpoints: Sørensen-Dice coefficient (DSC); Mean Distance to Agreement (MDA)

standards: ISO 14971, AAMI CR34971, IEC 62304 Edition 1.1 2015-06

Reported performance (3 observations)

diceas written: “Artery DSC”stated without valueCI [0.87, 0.90]
source quote (p.10)
“Artery DSC [0.87, 0.90]”
diceas written: “Parenchyma DSC”stated without valueCI [0.95, 0.97]
source quote (p.10)
“Parenchyma DSC [0.95, 0.97]”
diceas written: “Vein DSC”stated without valueCI [0.87, 0.89]
source quote (p.10)
“Vein DSC [0.87, 0.89]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251763 (decision 2025-12-16) from Intuitive Surgical, Inc. for a matching device line ("IRISeg") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251763

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/K242461