• 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 K201232
Device Name Limbus Contour
Limbus AI Inc.
2076 Athol St
Regina,  CA SK S4T 3E5
Applicant Contact Jon Giambattista
Medical Device Academy
245 Lincoln Hill Rd
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number892.2050
Classification Product Code
Date Received05/07/2020
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No