IRISEG

GUDID 00886874123676

IRISeg is a standalone software application for segmentation of medical images and generation of output files that can be rendered as a virtual 3D models.

INTUITIVE SURGICAL, INC.

Image segmentation application software

• Primary Device ID: 00886874123676
• NIH Device Record Key: ea60cd97-b931-4ad4-8de0-8d528966ba02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRISEG
• Version Model Number: 610700
• Company DUNS: 938647021
• Company Name: INTUITIVE SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874123676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242461

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-06
• Device Publish Date: 2025-02-26

Devices Manufactured by INTUITIVE SURGICAL, INC.

• 00886874123676 - IRISEG: 2025-03-06IRISeg is a standalone software application for segmentation of medical images and generation of output files that can be rendered as a virtual 3D models.
• 00886874123676 - IRISEG: 2025-03-06 IRISeg is a standalone software application for segmentation of medical images and generation of output files that can be render
• 00886874123447 - EndoWrist SP: 2024-12-17 FENESTRATED BIPOLAR FORCEPS
• 00886874123454 - EndoWrist SP: 2024-12-17 MONOPOLAR CURVED SCISSORS
• 00886874123461 - EndoWrist SP: 2024-12-17 MARYLAND BIPOLAR FORCEPS
• 00886874123478 - EndoWrist SP: 2024-12-17 NEEDLE DRIVER
• 00886874123843 - EndoWrist SP: 2024-12-17 CADIERE FORCEPS
• 00886874124031 - EndoWrist SP: 2024-12-17 ROUND TOOTH RETRACTOR ER
• 00886874124048 - EndoWrist SP: 2024-12-17 MONOPOLAR CURVED SCISSORS ER