FDA 510(k) Applications Submitted by Alaine Medio
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150192 |
01/28/2015 |
Scenium |
SIEMENS MEDICAL SOLUTIONS USA, INC |
| K210262 |
02/01/2021 |
Biograph Vision Quadra PET/CT System |
Siemens Medical Solutions USA, Inc. |
| K050509 |
03/01/2005 |
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I |
CTI PET SYSTEMS, INC. |
| K060631 |
03/09/2006 |
BIOGRAPH 64 AND BIOGRAPH 40 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K170904 |
03/28/2017 |
Biograph Horizon PET/CT |
Siemens Medical Solutions USA, Inc. |
| K180811 |
03/29/2018 |
Biograph Vision |
Siemens Medical Solutions USA, Inc. |
| K190900 |
04/08/2019 |
Biograph Vision |
Siemens Medical Solutions USA, Inc. |
| K211373 |
05/04/2021 |
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software |
Siemens Medical Solutions USA, Inc. |
| K081453 |
05/23/2008 |
BIOGRAPH HD FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K151486 |
06/02/2015 |
Biograph mCT and mCT Flow PET/CT Scanners |
Siemens Medical Solutions USA, Inc. |
| K101550 |
06/04/2010 |
BIOGRAPH MCT FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K231833 |
06/22/2023 |
Biograph Vision.X and Biograph Vision.X Edge |
Siemens Medical Solutions USA, Inc. |
| K141971 |
07/21/2014 |
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K192061 |
08/01/2019 |
SOMATOM Go Platform û SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO |
Siemens Medical Solutions USA, Inc. |
| K192402 |
09/03/2019 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
| K072567 |
09/12/2007 |
SYMBIA-E, MODEL 10275879 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K213096 |
09/24/2021 |
Al-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
| K152880 |
09/30/2015 |
Biograph Horizon PET/CT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K162736 |
09/30/2016 |
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT |
Siemens Medical Solutions USA, Inc. |
| K113029 |
10/11/2011 |
SYNGO VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K193178 |
11/18/2019 |
Biograph Horizon |
Siemens Medical Solution USA, Inc. |
| K113448 |
11/21/2011 |
BIOGRAPH MCT FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K173607 |
11/21/2017 |
SOMATOM Edge Plus |
Siemens Medical Solutions USA, Inc. |
| K103429 |
11/22/2010 |
BIOGRAPH MMR |
SIEMENS MEDICAL SOLUTIONS USA INC. |
| K093621 |
11/23/2009 |
SYNGO.PET&CT ONCOLOGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K223547 |
11/25/2022 |
Biograph Vision Quadra PET/CT System |
Siemens Medical Solutions USA, Inc. |
| K193267 |
11/26/2019 |
Al-Rad Companion (Musculoskeletal) |
Siemens Medical Solutions USA, Inc. |
| K193277 |
11/27/2019 |
SOMATOM On.site and On.scene |
Siemens Medical Solutions USA, Inc. |
| K203699 |
12/18/2020 |
syngo. CT Extended Functionalities |
Siemens Medical Solutions USA, Inc. |
| K214019 |
12/22/2021 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
| K083852 |
12/24/2008 |
BIOGRAPH 16 TRUE POINT SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K123577 |
11/20/2012 |
SYNGO.VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133644 |
11/27/2013 |
SYNGO.VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
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