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 System, X-Ray, Mobile
510(k) Number K241996
Device Name ULTRA 1040
Applicant
Ecoray Co., Ltd.
58, Wangsimni-Ro, Seongdong-Gu
#714~716, Forhu B/D
Seoul,  KR 04778
Applicant Contact Haeri Lee
Correspondent
Mansour Consulting, LLC
845 Aronsom Lake Court
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/09/2024
Decision Date 04/18/2025
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
-
-