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 Coil, Magnetic Resonance, Specialty
510(k) Number K033292
Device Name AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
Applicant
IGC-MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Applicant Contact ANTHONY DIETZLER
Correspondent
IGC-MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Correspondent Contact ANTHONY DIETZLER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/14/2003
Decision Date 11/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-