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, Image Processing, Radiological
510(k) Number K213128
Device Name IntraOp VSP Software Device
Applicant
Xironetic, LLC
712 N Broadway Ave
Oklahoma City,  OK  73102
Applicant Contact Christian El Amm
Correspondent
Paladin Medical, Inc
PO Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/27/2021
Decision Date 10/21/2022
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
-
-