• 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) | 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital mammography system
Regulation Number892.1715
ApplicantSIEMENS MEDICAL SOLUTION
PMA NumberP030010
Supplement NumberS006
Date Received10/13/2009
Decision Date11/05/2010
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the oem components (detector and image processing) developed by lorad, the mammomat novation, to an ffdm system that is designed solely from components designed or specified by siemens, the mammomat inspiration.
-
-