FDA 510(k) Applications Submitted by Siemens Medical Solutions USA, Inc
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150192 |
01/28/2015 |
Scenium |
SIEMENS MEDICAL SOLUTIONS USA, INC |
| K181098 |
04/26/2018 |
ACUSON SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K163252 |
11/18/2016 |
Mammomat Fusion with Stereotactic Biopsy |
SIEMENS MEDICAL SOLUTIONS USA, INC |
| K221305 |
05/05/2022 |
AI-Rad Companion Organs RT |
Siemens Medical Solutions USA, Inc |
| K251520 |
05/16/2025 |
Cios Alpha; Cios Flow |
Siemens Medical Solutions USA, Inc |
| K241569 |
05/31/2024 |
syngo Application Software |
Siemens Medical Solutions USA, Inc |
| K241572 |
05/31/2024 |
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) |
Siemens Medical Solutions USA, Inc |
| K233748 |
11/22/2023 |
CIARTIC Move (VB10) |
Siemens Medical Solutions USA, Inc |
| K162541 |
09/12/2016 |
syngo Application Software |
SIEMENS MEDICAL SOLUTIONS USA, INC |
| K170992 |
04/03/2017 |
AcuNav V 10F Ultrasound Catheter |
Siemens Medical Solutions USA, Inc |
| K200644 |
03/11/2020 |
ACUSON Freestyle Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K210743 |
03/12/2021 |
ACUSON Redwood Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K200707 |
03/18/2020 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K221500 |
05/23/2022 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K201462 |
06/02/2020 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K211859 |
06/16/2021 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K193257 |
11/26/2019 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K223735 |
12/13/2022 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
| K193248 |
11/25/2019 |
Biograph Vision, Biograph mCT Family of PET/CTs |
Siemens Medical Solutions USA, Inc |
| K151192 |
05/04/2015 |
syngo.via MI Workflows |
SIEMENS MEDICAL SOLUTIONS USA, INC |
| K162339 |
08/22/2016 |
Scenium |
SIEMENS MEDICAL SOLUTIONS USA, INC |
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