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 Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K130936
Device Name AERODR SYSTEM WITH P-31
Applicant
Konica Minolta Medical & Graphic, Inc.
140 E. 45th St., 25th Floor
Two Grand Central Tower
New York,  NY  10017
Applicant Contact RUSSEL MUNVES
Correspondent
Konica Minolta Medical & Graphic, Inc.
140 E. 45th St., 25th Floor
Two Grand Central Tower
New York,  NY  10017
Correspondent Contact RUSSEL MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received04/04/2013
Decision Date 08/22/2013
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
-
-