FDA.reportPublic FDA data

Quantaras Contour Companion

Primary DI
00860006956004
Brand
Quantaras Contour Companion
Company
Quantitative Radiology Solutions LLC
Model
QCCv1.0.0
Device description
Automatic contouring for radiation treatment planning.
Published
2021-09-27
Public version status
Update
Distribution status
Not 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
K203610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203610000Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC2021-04-20QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006956004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006956004008600069560048600069560040860006956004

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy treatment planning workstationA freestanding image processing device that is a component of radiation therapy treatment planning configuration. It is sometimes considered to be a component of a picture archiving and communication system (PACS) or a local area network (LAN) configuration, e.g., a radiology information system (RIS) or hospital information system (HIS). It does not contain any controls for the direct operation of a radiation therapy system. It can receive and transmit data both on-line and off-line and is configured to provide the capability to remotely process, manipulate and view patient images and information used in treatment planning, record and verification.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(267) 244-8012support@quantitativeradiologysolutions.com

Regulatory Flags#

DUNS number
079089213
Device count
1
Lot or batch
true

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
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
07340201500040AATMAElekta Solutions ABQKB2022-03-09