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 K090080
Device Name CIRRUS OPEN
Applicant
MRI-TECH SP. ZO.O.
206 - 3820 CAMBIE STREET
VANCOUVER, BC,  CA V5Z 2X7
Applicant Contact ANITA CHAN
Correspondent
MRI-TECH SP. ZO.O.
206 - 3820 CAMBIE STREET
VANCOUVER, BC,  CA V5Z 2X7
Correspondent Contact ANITA CHAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/12/2009
Decision Date 03/23/2009
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
-
-