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 Digital Pathology Image Viewing And Management Software
510(k) Number K243449
Device Name INFINITT DPS
Applicant
Infinitt Healthcare Co., Ltd.
12f Daerung Post Tower Iii
27 Digital-Ro 34-Gil, Guro-Gu
Seoul,  KR 08378
Applicant Contact Josh Baker
Correspondent
Infinitt Healthcare Co., Ltd.
12f Daerung Post Tower Iii
27 Digital-Ro 34-Gil, Guro-Gu
Seoul,  KR 08378
Correspondent Contact Josh Baker
Regulation Number864.3700
Classification Product Code
QKQ  
Date Received11/07/2024
Decision Date 12/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-