Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Accelerator, Linear, Medical
510(k) Number K150767
Device Name EDOSE
Applicant
Guangzhou Raydose Software Technology., LLC
#850 E. Dongfeng Rd., Guangzhou City,
Guangdong Province , P.R. China, Rm. 502, Glorious Tower
Guangzhou,  CN 510060
Applicant Contact DENNIS DONG
Correspondent
Guangzhou Raydose Software Technology., LLC
#850 E. Dongfeng Rd., Guangzhou City,
Guangdong Province , P.R. China, Rm. 502, Glorious Tower
Guangzhou,  CN 510060
Correspondent Contact DENNIS DONG
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/24/2015
Decision Date 08/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-