FDA.reportPublic FDA data

AutoContour

Primary DI
00850072631097
Brand
AutoContour
Company
Radformation, Inc
Model
Version 2.8
Device description
AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K262452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262452000AutoContour (RADAC V6)Radformation, Inc.2026-08-14QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850072631097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850072631097008500726310978500726310970850072631097

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Contacts#

Phone, Email table
PhoneEmail
(844) 723-3675support@radformation.com

Regulatory Flags#

DUNS number
080444608
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072631028ClearCheckVersion 2.72026-05-04
00850072631042AutoContourVersion 2.72026-03-30
00850072631004ClearCalcVersion 2.72026-03-13
00850072631035ChartCheckRADCH V1.62026-03-13
00850072631059ChartCheckVersion 1.72026-03-13
00860001672770ClearCheck V2RADCC V22026-03-13
00860001672787ClearCalcRADCA V2.62026-03-13
00860001672794EZFluenceVersion 2.52026-03-13
00860001672725ClearCalc2.02021-10-11
00860001672732AutoContour2.02021-10-11
00860001672701ClearCheck2.02021-10-04
00860001672718EZFluence2.32021-10-04
00860001672749ChartCheck1.22021-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04068151034189AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2026-06-23
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
00850009343345ContourProtégéAIMIM SOFTWARE INC.QKB2026-04-07
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