FDA.reportPublic FDA data

510(k) K221706

Device
AccuContour
Applicant
Manteia Technologies Co., Ltd.
510(k) number
K221706
Product code
QKB
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-09
Date received
2022-06-13
Regulation
892.2050
Classification name
Radiological Image Processing Software For Radiation Therapy
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dandan Chen
Address
1903, B Tower, Zijin Plz. # 1811 Huandao E. Rd. Xiamen CN 361001 361001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QKB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH2026-04-10
K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.2026-04-10
K253270Contour ProtégéAI+Mim Software, Inc.2026-03-27
K260509AutoContour (RADAC V5)Radformation, Inc.2026-03-19
K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.2026-01-28
K251351AccuContour 4.0Manteia Technologies Co., Ltd.2026-01-23
K250780ARTAssistantManteia Technologies Co., Ltd.2025-12-05
K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.2025-05-28
K242925MR Contour DLGE Healthcare2025-04-01
K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH2025-03-27
K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.2025-02-24
K250035Contour ProtégéAI+Mim Software, Inc.2025-02-03
K242729AutoContour (Model RADAC V4)Radformation, Inc.2024-12-09
K241490Contour+ (MVision AI Segmentation)Mvision AI OY2024-10-18
K241837Limbus ContourLimbus Ai, Inc.2024-10-09