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 ID00886874123676
NIH Device Record Keyea60cd97-b931-4ad4-8de0-8d528966ba02
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRISEG
Version Model Number610700
Company DUNS938647021
Company NameINTUITIVE SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886874123676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-06
Device Publish Date2025-02-26

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