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 Image Acquisition And/Or Optimization Guided By Artificial Intelligence
510(k) Number K251416
Device Name UltraSight Guidance
Applicant
Ultrasight , Ltd.
8 Pinhas St.
Ness Ziona,  IL 7403631
Applicant Contact Noa Avisar
Correspondent
Ultrasight , Ltd.
8 Pinhas St.
Ness Ziona,  IL 7403631
Correspondent Contact Noa Avisar
Classification Product Code
QJU  
Date Received05/07/2025
Decision Date 12/17/2025
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		 Yes
-
-