• 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 K150150
Device Name 1717SGN / 1717SCN Digital Flat Panel X-ray Detector
Rayence Co., Ltd
14, Samsung 1-ro, 1-gil
Hwaseong-si,  KR 445-170
Applicant Contact Kevin Kim
Mtech Group
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
Date Received01/23/2015
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No