• 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 interventional fluoroscopic x-ray system
510(k) Number K213455
Device Name ControlRad Select Model Z
Applicant
ControlRad, Inc.
275 Scientific Drive NW #1100
Norcross,  GA  30092
Applicant Contact Chris Fair
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Patricia Jones
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received10/26/2021
Decision Date 11/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-