• 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 K152138
Device Name FDR D-EVO GL Flat Panel Detector System
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Applicant Contact Katherine Y Choi
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Correspondent Contact Katherine Y Choi
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/31/2015
Decision Date 11/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-