• 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 K213215
Device Name VSI HoloMedicine
Applicant
ApoQlar GmbH
C/o The-Labs.Space,Raboisen 32
Hamberg,  DE 20095
Applicant Contact Liliana Duarte
Correspondent
ApoQlar GmbH
C/o The-Labs.Space,Raboisen 32
Hamberg,  DE 20095
Correspondent Contact Liliana Duarte
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/29/2021
Decision Date 11/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-