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 Radiological Computer-Assisted Triage And Notification Software
510(k) Number K240353
Device Name Hyper Insight - ICH
Applicant
SK Inc.
SK U-Tower, 9 Seongnam-daero, Bundang-gu
Seongnam-si,  KR 13558
Applicant Contact Jeffrey Choi
Correspondent
Empirical Technologies
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number892.2080
Classification Product Code
QAS  
Date Received02/05/2024
Decision Date 07/01/2024
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
-
-