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i2Contour

by Mrimath, LLC

510(k) K233822

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233822 Date8 Aug 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The i2Contour is a radiology device designed for contouring and segmentation in medical imaging, specifically for use in treatment planning workflows. It leverages AI-driven algorithms to enhance precision in delineating anatomical structures from MRI scans, supporting accurate radiotherapy and diagnostic assessments.

This device is supplied as a software-based solution, intended for use in radiology settings where MRI scans are analyzed. It is cleared for single-use applications within the context of its intended workflows and is classified under product code QIH. The i2Contour has received FDA 510(k) clearance through the Traditional pathway, ensuring compliance with regulatory standards for radiology devices.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What specific type of medical imaging does the i2Contour work with, and how does it improve treatment planning?

    The i2Contour is designed exclusively for MRI scans, where it uses AI-driven algorithms to improve the accuracy of contouring and segmentation. This process helps radiologists and treatment planners more precisely delineate anatomical structures, which is critical for radiotherapy planning and diagnostic assessments. By enhancing precision, it supports safer and more effective treatment workflows.

  • Is the i2Contour a standalone hardware device, or does it require integration with existing systems?

    The i2Contour is a software-based solution, meaning it does not require dedicated hardware but must be integrated into existing radiology workflows where MRI scans are analyzed. It is intended for use within radiology settings that already have the necessary infrastructure to support its AI-driven contouring capabilities.

  • How is the i2Contour supplied, and is it intended for single-use or reusable applications?

    The i2Contour is supplied as a software solution, which means it is not a physical consumable like a single-use or reusable device. However, the FDA clearance specifies it is intended for single-use applications within its designated workflows, implying each use case (e.g., a single MRI scan analysis) is treated as a discrete instance of use.

  • What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

    The i2Contour received FDA 510(k) clearance through the Traditional pathway, which means its safety and effectiveness were compared to a legally marketed predicate device. This clearance ensures compliance with U.S. regulatory standards for radiology devices, providing confidence in its use for contouring and segmentation in MRI-based treatment planning workflows.