Device
INTContour is FDA-cleared (K212274) AI-based image segmentation software intended to assist in radiation therapy treatment planning. The software performs automatic segmentation of...
Manufacturer
Carina Medical LLC
Carina Medical LLC
Model: 1.6.3
DI: 00860015780805
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
INTContour is FDA-cleared (K212274) AI-based image segmentation software intended to assist in radiation therapy treatment planning. The software performs automatic segmentation of anatomical structures including treatment targets and organs at risk on CT and MRI image series. INTContour is intended for use by qualified medical professionals; all output requires clinician review and approval before clinical use.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2eec90a5-a60d-4143-9a9e-f6c48fe89ed9
Distribution Status:
In Commercial Distribution
DUNS Number:
081070086
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860015780805
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47502
Name: Image segmentation application software
Definition:
An application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.
FDA Product Codes
MUJ
System, Planning, Radiation Therapy Treatment
QKB
Radiological Image Processing Software For Radiation Therapy
Premarket Submissions
Submission Number:
K212274
Supplement Number:
000