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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
Generic NameDigital breast tomosynthesis
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406
PMA NumberP140011
Supplement NumberS003
Date Received08/26/2016
Decision Date03/23/2017
Product Code OTE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The device, as modified, will be marketed under the trade name Mammomat Inspiration With Tomosynthesis Option and is indicated for use with the EMPIRE reconstruction algorithm for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer.A screening exam may consist of a:- 2D image set.- 3D DBT image set and a 2D FFDM image set or a- 3D DBT image set alone.
-
-