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 K961876
Device Name AIRIS
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 Received05/15/1996
Decision Date 07/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-