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 Triage And Notification Software
510(k) Number K200873
Device Name HALO
Applicant
Nico-Lab B.V.
Paasheuvelweg 25
Amsterdam,  NL 1105 BP
Applicant Contact Merel Boers
Correspondent
MD Squared BV
High Tech Campus 29
Eindhoven,  NL 5858 AE
Correspondent Contact Roujuan Zhang
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/01/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-