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 Camera, Multi Format, Radiological
510(k) Number K013052
Device Name KONICA LASER IMAGER, DRYPRO MODEL 751/752
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ISHIKAWA-CHO
HACHIOJI-SHI TOKYO,  JP 192-8505
Applicant Contact KOJIICHI KUBO
Correspondent
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ISHIKAWA-CHO
HACHIOJI-SHI TOKYO,  JP 192-8505
Correspondent Contact KOJIICHI KUBO
Regulation Number892.2040
Classification Product Code
LMC  
Date Received09/11/2001
Decision Date 01/16/2002
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
-
-