• 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 K063207
Device Name S-SCAN MRI SYSTEM
Applicant
ESAOTE, S.P.A.
11460 N MERIDIAN ST., STE 150
CARMEL,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
ESAOTE, S.P.A.
11460 N MERIDIAN ST., STE 150
CARMEL,  IN  46032
Correspondent Contact CARRI GRAHAM
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/23/2006
Decision Date 11/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-