• 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 K990153
Device Name VIRGO MRI SYSTEM
Applicant
MILLENNIUM TECHNOLOGY SERVICES
200 GREGORY LN., #C-100
PLEASANT HILL,  CA 
Applicant Contact DAVID W SCHLERF
Correspondent
MILLENNIUM TECHNOLOGY SERVICES
200 GREGORY LN., #C-100
PLEASANT HILL,  CA 
Correspondent Contact DAVID W SCHLERF
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/19/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-