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, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K212837
Device Name ProxiDiagnost N90
Applicant
Philips Medical Systems DMC GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Applicant Contact Supriya Dalvi
Correspondent
Philips Medical Systems DMC GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Correspondent Contact Supriya Dalvi
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/07/2021
Decision Date 09/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-