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 Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K220559
Device Name 17HQ901G-B
Applicant
LG Electronics Inc.
77, Sanho-daero
Gumi-si,  KR 39381
Applicant Contact Jinhwan Jun
Correspondent
GMS Consulting
4th Floor, Digital Cube, 34, Sangamsan-ro
Seoul,  KR 03909
Correspondent Contact Bokyeong Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/28/2022
Decision Date 05/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-