• 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 automated radiological image processing software
510(k) Number K210791
Device Name Us2.v1
eko.ai Pte. Ltd. d/b/a Us2.ai
2 College Road, #02-00
Singapore,  SG 94080
Applicant Contact James Hare
Enzyme Corporation
611 Gateway Blvd Ste 120
South San Francisco,  CA  94080
Correspondent Contact Jared Seehafer
Regulation Number892.2050
Classification Product Code
Date Received03/16/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No