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 K223758
Device Name Epione
Applicant
Quantum Surgical Sas
Zac Eureka 1000 Rue Du Mas De Verchant
Montpellier,  FR 34000
Applicant Contact Elise Lagacherie
Correspondent
Quantum Surgical Sas
Zac Eureka 1000 Rue Du Mas De Verchant
Montpellier,  FR 34000
Correspondent Contact Elise Lagacherie
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/15/2022
Decision Date 05/03/2023
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
Recalls CDRH Recalls
-
-