MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Premarket Approval P140011 S001

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 change to the indications for use statement. The device, as modified, will be marketed under the trade name mammomat inspiration with tomosynthesis option and is indicated for acquisition of 2d as well as 3d digital mammography images to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3d dbt image set and/or a 2d ffdm image set.

DeviceMAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
Classification NameDigital Breast Tomosynthesis
Generic NameDigital Breast Tomosynthesis
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
Date Received2015-11-23
Decision Date2016-05-12
PMAP140011
SupplementS001
Product CodeOTE
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
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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