MAMMOMAT Revelation with Tomosynthesis Option

FDA Premarket Approval P140011 S006

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.

Pre-market Approval Supplement Details

Approval for changes to the detector software and the tomosynthesis reconstruction pipeline

DeviceMAMMOMAT Revelation with Tomosynthesis Option
Generic NameDigital Breast Tomosynthesis
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
Date Received2019-09-12
Decision Date2019-12-10
PMAP140011
SupplementS006
Product CodeOTE 
Advisory CommitteeRadiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTIONS USA, INC. 51 Valley Stream Pkwy. malvern, PA 19355-1406

Supplemental Filings

Supplement NumberDateSupplement Type
P140011Original Filing
S007 2020-01-29 Normal 180 Day Track
S006 2019-09-12 Real-time Process
S005 2017-08-21 Real-time Process
S004
S003 2016-08-26 Normal 180 Day Track
S002 2015-12-23 Special (immediate Track)
S001 2015-11-23 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04056869001005 P140011 000
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