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, Image Processing, Radiological
510(k) Number K102684
Device Name XELIS DENTAL
Applicant
Infinitt Co., Ltd.
12f Daerung Post Tower Iii
182-4 Guro-Dong, Guro-Gu
Seoul,  KR 152-050
Applicant Contact TRISTAN CHOI
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/17/2010
Decision Date 10/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-