PMA P140011S002

Device: MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S002
Product code: OTE
Decision date: 2016-01-13
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order statement: APPROVAL TO IMPLEMENT A SOFTWARE UPDATE THAT RESOLVES AN ERROR THAT MAY OCCUR DURING TOMOSYNTHESIS RECONSTRUCTION WITH A BREAST THICKNESS LARGER THAN 90 MM.

Current openFDA PMA Record#

Device: MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S002
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2016-01-13
Decision code: APPR
Date received: 2015-12-23
Supplement type: Special (Immediate Track)
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO IMPLEMENT A SOFTWARE UPDATE THAT RESOLVES AN ERROR THAT MAY OCCUR DURING TOMOSYNTHESIS RECONSTRUCTION WITH A BREAST THICKNESS LARGER THAN 90 MM.