MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Premarket Approval P140011

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the mammomat inspiration with tomosynthesis option. This device is indicated for the acquisition of 2d as well as 3d digital mammography images to be used in screening and diagnosis of breast cancer. Each screening examination may consist of cc and mlo views in: a 2d image set, or a 2d and 3d image set. Note: the screening examination may consist of 2d ffdm images set with or without the 3d image set.

• Device: MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
• Classification Name: Digital Breast Tomosynthesis
• Generic Name: Digital Breast Tomosynthesis
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Received: 2014-06-26
• Decision Date: 2015-04-21
• Notice Date: 2015-05-18
• PMA: P140011
• Supplement: S
• Product Code: OTE
• Docket Number: 15M-1460
• Advisory Committee: Radiology
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 Valley Stream Pkwy. malvern, PA 19355-1406
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

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