• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name radiological image processing software for radiation therapy
510(k) Number K191928
Device Name AccuContour
Applicant
Xiamen Manteia Technology LTD.
1903, B Tower, Zijin Plaza, No.1811 Huandao East Road
xiamen,  CN 361001
Applicant Contact lu xie
Correspondent
Mid-Link Consulting Co. Ltd
P.O Box 120-119
shanghai,  CN 200120
Correspondent Contact diana hong
Regulation Number892.2050
Classification Product Code
QKB  
Date Received07/19/2019
Decision Date 02/28/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-