FDA 510(k) Applications Submitted by Siemens Medical Solutions USA Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K103429 11/22/2010 BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA INC.
K103127 10/22/2010 SOMATOM DEFINITION AS SIEMENS MEDICAL SOLUTIONS USA INC.
K220939 03/31/2022 MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A Siemens Medical Solutions USA Inc.
K223343 11/01/2022 MAGNETOM Amira; MAGNETOM Sempra Siemens Medical Solutions USA Inc.
K192924 10/16/2019 MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit Siemens Medical Solutions USA Inc.
K230421 02/16/2023 SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash Siemens Medical Solutions USA Inc.
K220450 02/17/2022 syngo.CT Applications Siemens Medical Solutions USA Inc.
K220783 03/17/2022 syngo.via RT Image Suite Siemens Medical Solutions USA Inc.
K211379 05/04/2021 syngo.via RT Image Suite Siemens Medical Solutions USA Inc.
K212889 09/10/2021 Syngo.CT Dual Energy Siemens Medical Solutions USA Inc.
K192496 09/11/2019 Magnetom Sola, Magnetom Altea and Magnetom Sola Fit Siemens Medical Solutions USA Inc.
K192462 09/09/2019 syngo.MR Applications Siemens Medical Solutions USA Inc.
K082220 08/06/2008 SOMATOM FLASH DS SIEMENS MEDICAL SOLUTIONS USA INC.
K223363 11/03/2022 MAMMOVISTA B.smart (VB70) Siemens Medical Solutions USA Inc.
K100619 03/04/2010 SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 SIEMENS MEDICAL SOLUTIONS USA INC.
K061054 04/17/2006 AXIOM ARISTOS FX PLUS SIEMENS MEDICAL SOLUTIONS USA INC.
K090038 01/06/2009 SYNGO BREVIS SIEMENS MEDICAL SOLUTIONS USA INC.
K070799 03/23/2007 MODULARIS VARIOSTAR SIEMENS MEDICAL SOLUTIONS USA INC.
K101347 05/13/2010 MAGNETOM AERA; MAGNETOM SKYRA SIEMENS MEDICAL SOLUTIONS USA 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.
K193283 11/27/2019 AI-Rad Companion Prostate MR Siemens Medical Solutions USA Inc.
K182299 08/24/2018 MAGNETOM Aera Siemens Medical Solutions USA Inc.
K183222 11/20/2018 MAGNETOM Terra Siemens Medical Solutions USA Inc.
K121160 04/16/2012 MAGNETOM SPECTRA SIEMENS MEDICAL SOLUTIONS USA INC.
K042617 09/24/2004 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA SIEMENS MEDICAL SOLUTIONS USA INC.
K223812 12/20/2022 Sensis Vibe (VD15) Siemens Medical Solutions USA Inc.
K050240 02/02/2005 MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM SIEMENS MEDICAL SOLUTIONS USA INC.
K123622 11/23/2012 ACUSON SIEMENS MEDICAL SOLUTIONS USA INC.
K061980 07/13/2006 SIEMENS ACUSON X500 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA INC.
K081808 06/26/2008 ACUNAV V ULTRASOUND CATHETER SIEMENS MEDICAL SOLUTIONS USA INC.


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