Intuitive Surgical, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K251763

IRISeg

Intuitive Surgical, Inc.

Authorized purpose: IRISeg accepts MR or contrast-enhanced CT images for manual and machine-learning image analysis and segmentation and produces visual three-dimensional models for preoperative planning or intraoperative display; output is non-diagnostic and requires clinician decisions.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Kidneys and other patient-specific surgical anatomy
Decision: 2025-12-16

Quantification and segmentation

FDA-cleared K242461

IRISeg

Intuitive Surgical Inc.

Authorized purpose: IRISeg receives DICOM-compliant contrast-enhanced CT images, provides manual and machine-learning-enabled image-analysis and segmentation tools, and creates an output file for a three-dimensional model used in preoperative planning and intraoperative display. The kidney CT auto-segmentation tool is indicated for adult patients with contrast-enhanced axial kidney CT images with slice thickness of 3 mm or less.

Modality: CT/CTA
Anatomy: Kidneys
Decision: 2024-12-10

Quantification and segmentation