• 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 K953918
Device Name MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1963 CASE PKWY.
TWINSBURG,  OH  44087
Applicant Contact JAMES J ROGERS
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1963 CASE PKWY.
TWINSBURG,  OH  44087
Correspondent Contact JAMES J ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/18/1995
Decision Date 09/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-