AccuContour

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 ID: K191928
• 510k Number: K191928
• Device Name: AccuContour
• Classification: Radiological Image Processing Software For Radiation Therapy
• Applicant: Xiamen Manteia Technology LTD. 1903, B Tower, Zijin Plaza, No.1811 Huandao East Road Xiamen, CN 361001
• Contact: Lu Xie
• Correspondent: Diana Hong; Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai, CN 200120
• Product Code: QKB
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-19
• Decision Date: 2020-02-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
16973127400019	K191928	000
06973127400029	K191928	000