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, X-Ray, Tomography, Computed
510(k) Number K153004
Device Name Clear Guide SCENERGY
Applicant
CLEAR GUIDE MEDICAL
3600 Clipper Mill Road, Suite 400
Baltimore,  MD  21211
Applicant Contact Jack Kent
Correspondent
CLEAR GUIDE MEDICAL
3600 Clipper Mill Road, Suite 400
Baltimore,  MD  21211
Correspondent Contact Jack Kent
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/13/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-