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 K123995
Device Name MICRODOSE SI
Applicant
Philips Digital Mammography Sweden AB
Smidesvagen 5
Solna,  SE SE-171 41
Applicant Contact GUSTAV LINS
Correspondent
Philips Digital Mammography Sweden AB
Smidesvagen 5
Solna,  SE SE-171 41
Correspondent Contact GUSTAV LINS
Regulation Number892.1715
Classification Product Code
MUE  
Date Received12/26/2012
Decision Date 02/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-