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 K950610
Device Name FIKO FO;, TJER,A; O,AGER FTO-1000
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD,  CT  06912 -0035
Applicant Contact OBERT A UZENOFF
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD,  CT  06912 -0035
Correspondent Contact OBERT A UZENOFF
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/10/1995
Decision Date 04/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-