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 X-Ray, Tomography, Computed, Dental
510(k) Number K123332
Device Name NAOMI-CT
Applicant
LK CONSULTING GROUP
1515 E KATELLA AVE. UNIT 2115
ANAHEIM,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
LK CONSULTING GROUP
1515 E KATELLA AVE. UNIT 2115
ANAHEIM,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number892.1750
Classification Product Code
OAS  
Date Received10/26/2012
Decision Date 07/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-