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 Prioritization Software For Lesions
510(k) Number K213941
Device Name Annalise Enterprise CXR Triage Pneumothorax
Applicant
Annalise-AI
Level 21, 60 Margaret Street
Sydney,  AU 2000
Applicant Contact Eric Qin
Correspondent
Annalise-AI
Level 21, 60 Margaret Street
Sydney,  AU 2000
Correspondent Contact Michele Houldsworth
Regulation Number892.2080
Classification Product Code
QFM  
Date Received12/16/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-