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.

• Device: MAMMOMAT Revelation with Tomosynthesis Option System
• Generic Name: Digital Breast Tomosynthesis
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Received: 2020-01-29
• Decision Date: 2020-08-21
• PMA: P140011
• Supplement: S007
• Product Code: OTE
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 Valley Stream Pkwy. malvern, PA 19355-1406

Supplemental Filings

Supplement Number	Date	Supplement Type
P140011		Original 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 ID	PMA	Supp
04056869001005	P140011	000