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 Automated Radiological Image Processing Software
510(k) Number K231683
Device Name inHEART Models
Applicant
inHEART, SAS
IHU LIryc – Hôpital Xavier Arnozan-Avenue du Haut Lévêque
Pessac,  FR 33600
Applicant Contact Audrey Labeque
Correspondent
inHEART, SAS
IHU LIryc – Hôpital Xavier Arnozan-Avenue du Haut Lévêque
Pessac,  FR 33600
Correspondent Contact Audrey Labeque
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received06/09/2023
Decision Date 02/29/2024
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
-
-