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, Image Processing, Radiological
510(k) Number K091687
Device Name PACSMATE, MODEL MMD-4300C/MMD-4300CX
Applicant
Iei Technology Corp.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Iei Technology Corp.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/10/2009
Decision Date 07/07/2009
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
-
-