FDA.reportPublic FDA data

ContourProtégéAI

Primary DI
00850009343345
Brand
ContourProtégéAI
Company
MIM SOFTWARE INC.
Model
1.4
Device description
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
Published
2026-04-07
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
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250035000Contour ProtégéAI+Mim Software, Inc.2025-02-03QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009343345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009343345008500093433458500093433450850009343345

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Contacts#

Phone, Email table
PhoneEmail
216-455-0600qnr@mimsoftware.com

Regulatory Flags#

DUNS number
136977290
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009343352MIM7.52026-01-30
00850009343710MIM7.4.2002026-01-30
00850009343192MIM7.22021-09-24
00850009343321MIM7.4.702025-05-30
00850009343024MIM7.12020-10-08
00850009343307ContourProtégéAI1.32024-03-20
00850009343284MIM7.42024-02-08
00860148000863MIM7.02019-10-10
00860148000894Mobile MIM4.22020-05-22
00850009343291ContourProtégéAI1.22023-08-20
00850009343031MIMcloud2.122020-06-16
00850009343277MIM7.32022-11-09
00850009343178ContourProtégéAI - CT Abdomen2.02022-05-16
00850009343215ContourProtégéAI - CT Lung and Liver2.02022-05-16
00850009343239ContourProtégéAI - CT SurePlan MRT1.02022-05-16
00850009343130MIMcloud2.132020-11-30
00850009343055ContourProtégéAI - CT Head and Neck1.02020-10-13
00850009343062ContourProtégéAI - CT Thorax1.02020-10-13
00850009343079ContourProtégéAI - CT Liver1.02020-10-13
00850009343086ContourProtégéAI - CT Prostate 1.02020-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809839660001OncoStudioOncoSoft. co.,Ltd.QKB2026-05-08
00860015780805INTContourCarina Medical LLCQKB2026-04-27
06973127400098AccuContourManteia Technologies Co.,Ltd.QKB2026-04-27
00860010267103DeepContourWisdom Technologies, IncQKB2026-04-22
06973127400135ARTAssistantManteia Technologies Co.,Ltd.QKB2026-04-22
00850072631042AutoContourRadformation, IncQKB2026-03-30
00860009223660Neosoma Brain MetsNeosoma, Inc.QKB2026-02-10
00198953043387MR Contour DLGE HEALTHCAREQKB2026-01-23
03770019940013ART-PlanTHERAPANACEAQKB2025-12-10
03770019940020ART-PlanTHERAPANACEAQKB2025-12-10
06973127400029AccuContourManteia Technologies Co.,Ltd.QKB2025-06-16
04068151010404AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2025-06-05
04056869973371AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2025-04-30
00628011382184Limbus ContourLimbus Ai Inc.QKB2025-02-19
06429830064206Contour+ (MVision AI Segmentation) Mvision AI OyQKB2024-12-31
00195278560384Auto SegmentationGE Medical Systems, L.L.C.QKB2024-11-05
00850009343307ContourProtégéAIMIM SOFTWARE INC.QKB2024-03-20
00850009343291ContourProtégéAIMIM SOFTWARE INC.QKB2023-08-20
04719884900011VBrainVysioneer Inc.QKB2023-08-08
06973127400050AccuContourManteia Technologies Co.,Ltd.QKB2023-04-01
07350097430017MRI PlannerSpectronic Medical ABQKB2023-01-31
08800025300145AVIEW RT ACSCORELINE SOFT CO.,LTD.QKB2022-11-30
04056869955667AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2022-11-09
03770019940006ART-PlanTHERAPANACEAQKB2022-10-26
00850009343178ContourProtégéAI - CT AbdomenMIM SOFTWARE INC.QKB2022-05-16
00850009343215ContourProtégéAI - CT Lung and LiverMIM SOFTWARE INC.QKB2022-05-16
00850009343239ContourProtégéAI - CT SurePlan MRTMIM SOFTWARE INC.QKB2022-05-16
06975191150008RT-Mind-AIMedMind Technology Co., Ltd.QKB2022-03-15
07340201500040AATMAElekta Solutions ABQKB2022-03-09
00860001672732AutoContourRadformation, IncQKB2021-10-11