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, Tomography, Computed, Emission
510(k) Number K180077
Device Name NeuroQ 3.8
Applicant
Syntermed
245 S. Owens Dr.
Anaheim,  CA  92808
Applicant Contact Kenneth Van Train
Correspondent
Syntermed
245 S. Owens Dr.
Anaheim,  CA  92808
Correspondent Contact Kenneth Van Train
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/10/2018
Decision Date 08/16/2018
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
-
-