Radiological Image Processing Software For Radiation Therapy

Xiamen Manteia Technology LTD.

The following data is part of a premarket notification filed by Xiamen Manteia Technology Ltd. with the FDA for Accucontour.

Pre-market Notification Details

Device IDK191928
510k NumberK191928
Device Name:AccuContour
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Xiamen Manteia Technology LTD. 1903, B Tower, Zijin Plaza, No.1811 Huandao East Road Xiamen,  CN 361001
ContactLu Xie
CorrespondentDiana Hong
Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-19
Decision Date2020-02-28

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