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, nuclear magnetic resonance imaging
510(k) Number K994283
Device Name MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
Applicant
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
POORTGEBOUW RIJNSBURGERWEG 10
LEIDEN,  NL 2333 AA
Applicant Contact J.I. HOLLANDER
Correspondent
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
POORTGEBOUW RIJNSBURGERWEG 10
LEIDEN,  NL 2333 AA
Correspondent Contact J.I. HOLLANDER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/20/1999
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-