The following data is part of a premarket notification filed by Xiamen Manteia Technology Ltd. with the FDA for Accucontour.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
16973127400019 | K191928 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCUCONTOUR 88812245 not registered Live/Pending |
Manteia Technologies Co.,Ltd. 2020-02-26 |
ACCUCONTOUR 88812113 not registered Live/Pending |
Manteia Technologies Co.,Ltd. 2020-02-26 |