FDA 510(k) Applications Submitted by Siemens Medical Solutions, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K041029 |
04/21/2004 |
KINETDX |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K073003 |
10/24/2007 |
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K132094 |
07/08/2013 |
CIOS ALPHA |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K042793 |
10/07/2004 |
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K181279 |
05/15/2018 |
Ysio Max |
Siemens Medical Solutions, Inc. |
| K182517 |
09/13/2018 |
MULTIX Impact |
Siemens Medical Solutions, Inc. |
| K182639 |
09/24/2018 |
MOBILETT Elara Max |
Siemens Medical Solutions, Inc. |
| K173408 |
11/01/2017 |
Mammomat Revelation |
Siemens Medical Solutions, Inc. |
| K162102 |
07/29/2016 |
MAGNETOM Avantofit, MAGNETOM Skyrafit |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K153343 |
11/19/2015 |
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K153360 |
11/20/2015 |
ADMIRE |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K062454 |
08/22/2006 |
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K052423 |
09/02/2005 |
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K142628 |
09/16/2014 |
Acuson SC2000 Diagnostic Ultrasound System |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K133643 |
11/27/2013 |
SYNGO, CT LIVER ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K162417 |
08/30/2016 |
Acuson Freestyle Ultrasound System |
Siemens Medical Solutions, Inc. |
| K121434 |
05/14/2012 |
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K042718 |
09/30/2004 |
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K150493 |
02/25/2015 |
Sensis |
Siemens Medical Solutions, Inc. |
| K131812 |
06/19/2013 |
SENSIS, SENSIS LITE |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K132934 |
09/18/2013 |
MULTIX SELECT DR |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K130754 |
03/19/2013 |
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K112020 |
07/14/2011 |
SYNGO.CT VASCULAR ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K090334 |
02/10/2009 |
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS, INC. |
| K162243 |
08/10/2016 |
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System |
Siemens Medical Solutions, Inc. |
| K093531 |
11/16/2009 |
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS, INC. |
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