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 System, Image Processing, Radiological
510(k) Number K230772
Device Name Quantib Prostate
Applicant
Quantib BV
Westblaak 130
Rotterdam,  NL 3012 KM
Applicant Contact Floor van Leeuwen
Correspondent
Quantib BV
Westblaak 130
Rotterdam,  NL 3012 KM
Correspondent Contact Floor van Leeuwen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/21/2023
Decision Date 04/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-