FDA.reportPublic FDA data

INTContour

Primary DI
00860015780805
Brand
INTContour
Company
Carina Medical LLC
Model
1.6.3
Device 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.
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUJSystem, Planning, Radiation Therapy Treatment
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212274000INT ContourCarina Medical, LLC2022-04-08MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015780805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015780805008600157808058600157808050860015780805

GMDN Terms#

Term, Definition table
TermDefinition
Image segmentation application software"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."

Contacts#

Phone, Email table
PhoneEmail
+1-434-284-1073support@carinaai.com

Regulatory Flags#

DUNS number
081070086
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015780812INTDose1.6.32026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953200933Contour ProtégéAIMIM SOFTWARE INC.QKB2026-10-17
00859032007392Panther TPSProwess, Inc.MUJ2026-10-14
00859032007385Panther OISProwess, Inc.MUJ2026-09-22
00850072631097AutoContourRadformation, IncQKB2026-08-25
00860007402395TrueFit BolusAdaptiiv Medical Technologies IncMUJ2026-06-24
04068151027280syngo.via RT Image Suite VC10Siemens Healthcare GmbHMUJ2026-06-24
04068151034189AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2026-06-23
00859032007361Panther OISProwess, Inc.MUJ2026-06-09
00859032007378Panther TPSProwess, Inc.MUJ2026-06-09
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Philips Medical Systems Nederland B.V.MUJ2026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradePhilips Medical Systems Nederland B.V.MUJ2026-06-07
00859032007316Panther TPSProwess, Inc.MUJ2026-06-01
00859032007323Panther TPSProwess, Inc.MUJ2026-06-01
00859032007330Panther OISProwess, Inc.MUJ2026-06-01
00859032007347Panther TPSProwess, Inc.MUJ2026-06-01
00859032007354Panther OISProwess, Inc.MUJ2026-06-01
08809839660001OncoStudioOncoSoft. co.,Ltd.QKB2026-05-08
06973127400098AccuContourManteia Technologies Co.,Ltd.QKB2026-04-27
00860010267103DeepContourWisdom Technologies, IncQKB2026-04-22
06973127400135ARTAssistantManteia Technologies Co.,Ltd.QKB2026-04-22
08436567540024RadianceGMV SOLUCIONES GLOBALES INTERNET SAMUJ2026-04-08
00850009343345ContourProtégéAIMIM SOFTWARE INC.QKB2026-04-07
00850072631042AutoContourRadformation, IncQKB2026-03-30
07340201500118MonacoElekta Solutions ABMUJ2026-03-20
00850072631004ClearCalcRadformation, IncMUJ2026-03-13
00860001672787ClearCalcRadformation, IncMUJ2026-03-13
00860001672794EZFluenceRadformation, IncMUJ2026-03-13
00860009223660Neosoma Brain MetsNeosoma, Inc.QKB2026-02-10
07340201503898Leksell GammaPlanElekta Solutions ABMUJ2026-02-04
00198953043387MR Contour DLGE HEALTHCAREQKB2026-01-23