FDA 510(k) Applications Submitted by Kimberly Mangum
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120579 |
02/27/2012 |
SOMATOM DEFINITION EDGE |
SIEMENS MEDICAL SYSTEMS, INC. |
| K190578 |
03/06/2019 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence |
Siemens Medical Solutions USA Inc. |
| K150757 |
03/23/2015 |
syngo.CT Dual Energy |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K150745 |
03/23/2015 |
syngo.CT Single Source Dual Energy |
Siemens Medical Solutions USA, Inc. |
| K170952 |
03/31/2017 |
syngo.CT View&GO |
Siemens Medical Solutions USA, Inc. |
| K130901 |
04/01/2013 |
SOMATOM DEFINITION AS OPEN |
SIEMENS MEDICAL SYSTEMS, INC. |
| K121072 |
04/09/2012 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
| K140920 |
04/10/2014 |
SYNGO.CT COLONOGRAPHY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K161196 |
04/27/2016 |
SOMATOM Drive |
Siemens Medical Solutions USA, Inc. |
| K151765 |
06/30/2015 |
SOMATOM Perspective |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K151887 |
07/10/2015 |
syngo VSim |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K152036 |
07/22/2015 |
SOMATOM Definition Edge, SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K162302 |
08/17/2016 |
Somatom Confidence « RT Pro |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K162370 |
08/24/2016 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
| K132902 |
09/16/2013 |
SYNGO DUAL ENERGY SOFTWARE PACKAGE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K122909 |
09/21/2012 |
SYNGO SINGLE SOURCE DUAL ENGERY |
SIEMENS MEDICAL SYSTEMS, INC. |
| K142955 |
10/14/2014 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K153220 |
11/06/2015 |
syngo.CT Single Source Dual Energy (Twin Beam) |
Siemens Medical Solutions USA, Inc. |
| K133424 |
11/08/2013 |
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K123540 |
11/19/2012 |
SYNGO CT PULMO 3D |
SIEMENS MEDICAL SYSTEMS, INC. |
| K123541 |
11/19/2012 |
SYNGO.CT NEURO PERFUSION |
SIEMENS MEDICAL SYSTEMS, INC. |
| K123585 |
11/21/2012 |
SYNGO, CT CARDIAC FUNCTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K123584 |
11/21/2012 |
SYNGO, CT BONE READING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133590 |
11/22/2013 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133589 |
11/22/2013 |
SOMATOM FORCE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K163284 |
11/22/2016 |
syngo. CT Neuro Perfusion |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K163289 |
11/22/2016 |
syngo. CT Single Source Dual Energy (twin beam) |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K163296 |
11/22/2016 |
SOMATOM go.Up, SOMATOM go.Now |
Siemens Medical Solutions USA, Inc. |
| K163297 |
11/22/2016 |
Scan&GO |
Siemens Medical Solutions USA, Inc. |
| K183271 |
11/23/2018 |
AI-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
| K183272 |
11/23/2018 |
AI Rad Companion (Engine) |
Siemens Medical Solutions USA, Inc. |
| K173625 |
11/24/2017 |
syngo.CT Clinical Extensions |
Siemens Medical Solutions USA, Inc. |
| K173630 |
11/24/2017 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence |
Siemens Medical Solutions USA, Inc. |
| K173632 |
11/24/2017 |
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO |
Siemens Medical Solutions USA, Inc. |
| K173635 |
11/24/2017 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
| K173637 |
11/24/2017 |
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis |
Siemens Medical Solutions USA, Inc. |
| K133648 |
11/27/2013 |
SYNGO, CT DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133646 |
11/27/2013 |
ADMIRE |
SIEMENS MEDICAL SYSTEMS, INC. |
| K133643 |
11/27/2013 |
SYNGO, CT LIVER ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K143401 |
11/28/2014 |
SOMATOM Definition Edge |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K143400 |
11/28/2014 |
SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133677 |
11/29/2013 |
SYNGO CT SINGLE SOURCE DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K163341 |
11/29/2016 |
syngo.CT Extended Functionality |
SIEMENS MEDICAL SOLUTIONS USA, Inc. |
| K213867 |
12/10/2021 |
Carestation 750/750c |
Datex-Ohmeda, Inc. |
| K183548 |
12/20/2018 |
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 |
Siemens Medical Solutions USA, Inc. |
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