• 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, image processing, radiological
510(k) Number K230575
Device Name Limbus Contour
Limbus AI Inc.
2375 College Ave
Regina,  CA S4P0S8
Applicant Contact Jon Giambattista
Medical Device Academy
345 Lincoln Hill Rd
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number892.2050
Classification Product Code
Date Received03/01/2023
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No