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 Full Field Digital, System, X-Ray, Mammographic
510(k) Number K133972
Device Name ASPIRE CRISTALLE
Applicant
FUJIFILM MEDICAL SYSTEMS, USA INC.
419 WEST AVE.
STANFORD,  CT  06902
Applicant Contact PETER ALTMAN
Correspondent
FUJIFILM MEDICAL SYSTEMS, USA INC.
419 WEST AVE.
STANFORD,  CT  06902
Correspondent Contact PETER ALTMAN
Regulation Number892.1715
Classification Product Code
MUE  
Date Received12/26/2013
Decision Date 03/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-