• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122286
Device Name MAMMOMAL INSPIRATION
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern,  PA  19355
Original Contact patricia d jones
Regulation Number892.1715
Classification Product Code
MUE  
Date Received07/30/2012
Decision Date 02/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-