# Siemens Medi Cal Solutions, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 32 (2004–2020): 32 510(k) clearances
- Product codes: IYN (7), LNH (5), JAK (4), LLZ (3), KPR (3), OWB (3), DQK (2), OEB (1), MUE (1), IZL (1), IYO (1), MOS (1)
- 510(k) review time since 2016: median 118 days, against 64 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 69 (2 its own); citations of its devices by later devices: 79 (2 its own)
- Recalls linked to its devices: 55 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 36 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens AG Medical Solutions: 5 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Siemens Medical Systems, Inc.: 4 (https://510kreport.com/company/siemens-medical-systems)
- Siemens Medical Solution: 3 (https://510kreport.com/company/siemens-medical-solution)
- Siemens Medical Solutions USA, Inc. Ultrasound Group: 2 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-group)
- Siemens Medical Solutions USA, Inc., Ultrasound DI: 2 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di)
- Penrith Corporation: 1 (https://510kreport.com/company/penrith)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 51 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens AG Medical Solutions: 3 (https://510kreport.com/company/siemens-ag-medical-solutions)
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Siemens Medical Solution: 2 (https://510kreport.com/company/siemens-medical-solution)
- Philips Medical Systems Nederland B.V.: 2 (https://510kreport.com/company/philips-medical-systems-nederland)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)
- Siemens Healthcare GmbH: 1 (https://510kreport.com/company/siemens-healthcare)
- Ionic Health: 1 (https://510kreport.com/company/ionic-health)

## Its most-cited devices
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), cited by 16
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (2016), cited by 8
- K112020: Syngo.CT Vascular Analysis (2011), cited by 6
- K052423: Magnetom Systems with Syngo Expert - I Option (2006), cited by 6
- K132094: Cios Alpha (2014), cited by 5
- K090334: Acuson S2000 Diagnostic Ultrasound System (2009), cited by 4

## Recent decisions
- K193216: syngo.CT Lung CAD (Mar 9, 2020)
- K182639: MOBILETT Elara Max (Mar 15, 2019)
- K182517: MULTIX Impact (Jan 11, 2019)
- K181279: Ysio Max (Jun 13, 2018)
- K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (Apr 2, 2018)
- K173408: Mammomat Revelation (Mar 21, 2018)
- K172832: Insight BD (Feb 6, 2018)
- K171766: Acuson SC2000 Diagnostic Ultrasound System (Jul 12, 2017)

Source page: https://510kreport.com/company/siemens-medi-cal-solutions