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 K151465
Device Name AeroDR SYSTEM 2
Applicant
KONICA MINOLTA, INC.
1 SAKURA-MACHI
HINO-SHI,  JP 191-8511
Applicant Contact SHIGEYUKI KOJIMA
Correspondent
STORCH AMINI & MUNVES PC
140 EAST 45TH STREET, 25TH FLOOR
NEW YORK,  NY  10017
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received06/01/2015
Decision Date 06/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-