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, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K242239
Device Name HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
Applicant
Gentuity, LLC
142 North Road, Suite G
Sudbury,  MA  01776
Applicant Contact Edwin Rule
Correspondent
Gentuity, LLC
142 North Road, Suite G
Sudbury,  MA  01776
Correspondent Contact Sharon Timberlake
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Code
DQO  
Date Received07/30/2024
Decision Date 08/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-