MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Premarket Approval P140011 S003

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

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.

• Device: MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
• Classification Name: Digital Breast Tomosynthesis
• Generic Name: Digital Breast Tomosynthesis
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Received: 2016-08-26
• Decision Date: 2017-03-23
• PMA: P140011
• Supplement: S003
• Product Code: OTE
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• 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