Siemens Medical Solutions USA, Inc

FDA Filings

This page includes the latest FDA filings for Siemens Medical Solutions USA, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Siemens Medical Solutions USA, Inc.
Somatom Go Platform – Somatom Go.now, Go.up, Go.all, Go.top, Go.sim, Go.open Pro, Scan & Go2019-11-21
Siemens Medical Solutions USA, Inc.
SOMATOM X.cite2019-11-06
Siemens Medical Solutions USA, Inc.
ACUSON P200 Diagnostic Ultrasound System2019-08-15
Siemens Medical Solutions USA, Inc.
AI-Rad Companion (Pulmonary)2019-07-26
Siemens Medical Solutions USA, Inc.
Syngo.MR Applications2019-07-05
Siemens Medical Solutions USA Inc.
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence2019-06-27
Siemens Medical Solutions USA, Inc.
Multix Fusion Max2019-06-19
Siemens Medical Solutions USA, Inc.
Biograph Vision2019-05-06
Siemens Medical Solutions USA, Inc.
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 162019-04-15
Siemens Medical Solutions USA Inc.
MAGNETOM Terra2019-02-15
Siemens Medical Solutions USA, Inc.
MAGNETOM Aera2019-02-15
Siemens Medical Solutions USA, Inc.
MAGNETOM Amira, MAGNETOM Sempra2019-02-14
Siemens Medical Solutions USA, Inc.
AI Rad Companion (Engine)2019-02-01
Siemens Medical Solutions USA, Inc.
MAGNETOM Lumina2019-01-24
Siemens Medical Solutions USA, Inc.
MAGNETOM Avanto, MAGNETOM Verio With Software Syngo MR E11D2018-11-06
Siemens Medical Solutions USA, Inc.
Cios Spin2018-10-30
Siemens Medical Solutions USA Inc.
MAGNETOM Aera2018-10-26
Siemens Medical Solutions USA, Inc.
MAGNETOM Vida2018-10-19
Siemens Medical Solutions USA, Inc.
MAGNETOM Sola2018-10-12
Siemens Medical Solutions USA, Inc.
MAGNETOM Sola2018-10-05
Siemens Medical Solutions USA, Inc.
Linear Accelerator Control Console Software V13.1.010 Update, Syngo Radiation Therapy Therapist V4.3.1_MR3 Patch, Syngo Radiation Therapy Oncologist V4.3.1_MR3 Patch2018-10-03
Siemens Medical Solutions USA, Inc.
Cios Select2018-08-17
Siemens Medical Solutions USA, Inc
ACUSON SC2000 Diagnostic Ultrasound System2018-05-31
Siemens Medical Solutions USA, Inc.
Biograph Vision2018-05-23
Siemens Medical Solutions USA, Inc.
Syngo.MR Applications2018-04-19
Siemens Medical Solutions USA, Inc.
SOMATOM Go.Up, SOMATOM Go.Now, SOMATOM Go.Top, SOMATOM Go.All, Scan&GO2018-04-13
Siemens Medical Solutions USA, Inc.
Syngo.via MI Workflows2018-04-05
Siemens Medical Solutions USA, Inc.
Scenium VE20 Software2018-04-04
Siemens Medical Solutions USA, Inc.
MAGNETOM Vida With Compressed Sensing GRASP-VIBE2018-03-30
Siemens Medical Solutions USA, Inc.
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence2018-03-30

Latest Premarket Applications

PMAManufacturerDevice NameDate
SIEMENS MEDICAL SOLUTIONS USA, INC.
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option2017-09-29
SIEMENS MEDICAL SOLUTIONS USA, INC.
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION2017-03-23
SIEMENS MEDICAL SOLUTIONS USA, INC.
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION2016-05-12
SIEMENS MEDICAL SOLUTIONS USA, INC.
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION2016-01-13
SIEMENS MEDICAL SOLUTIONS USA, INC.
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION2015-04-21

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
BP10-3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
EV-8C4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
10MC3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
18H5 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
9VE3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
8VC3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
9MC3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
10MC3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
VF13-5SP Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
4Z1c Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-21
MC9-4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
EC10-5w Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
EC9-4w Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
BP9-4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
EV9F3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
EC9-4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
EC9-4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
14L5SP Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
ACUSON S2000 Automated Breast Volume Scanner
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
EC9-4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-15
Biograph Vision 600 (8 Ring/64 CT)
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-14
Biograph Vision 600 Edge (8 Ring/Edge)
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-14
ACUSON Sequoia Diagnostic Ultrasound System
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-14
5.0CW Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
2.0CW Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
5V1 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
5C1 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
ACUSON Redwood Diagnostic Ultrasound System
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
10V4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
8V3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
4V1 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
14L5 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
18L6 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
10L4 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28
9C3 Transducer
SIEMENS MEDICAL SOLUTIONS USA, INC.2019-10-28

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.