MAMMOMAT Revelation with Tomosynthesis Option System

FDA Premarket Approval P140011 S007

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 1) a new processing scheme for synthetic mammograms (new insight 2d/3d), and 2) an updated indications for use to include digital breast tomosynthesis (dbt) in combination with synthesized image sets, insight 2d, or insight 2d and insight 3d, as a screening mode, for mammomat revelation with tomosynthesis option.

DeviceMAMMOMAT Revelation with Tomosynthesis Option System
Generic NameDigital Breast Tomosynthesis
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
Date Received2020-01-29
Decision Date2020-08-21
PMAP140011
SupplementS007
Product CodeOTE 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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04056869001005 P140011 000

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