# Siemens Medical Solutions

- Location (FDA's records): Malvern, PA
- FDA decisions: 15 (2003–2025): 15 510(k) clearances
- Product codes: LLZ (4), KPR (3), OWB (3), LNH (1), JAK (1), MHX (1), IZL (1), MOS (1)
- 510(k) review time since 2016: median 142 days, against 90 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 35 (2 its own); citations of its devices by later devices: 22 (2 its own)
- Recalls linked to its devices: 4 (0 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.: 17 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Acuson Corp.: 4 (https://510kreport.com/company/acuson)
- Siemens Ultrasound, Inc.: 2 (https://510kreport.com/company/siemens-ultrasound)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Siemens AG Medical Solutions: 1 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Adac Laboratories: 1 (https://510kreport.com/company/adac-laboratories)
- General Electric Medical Systems: 1 (https://510kreport.com/company/general-electric-medical-systems)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Firms that cite its devices most
- Esaote, S.p.A.: 3 (https://510kreport.com/company/esaote)
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medical Systems Nederland B.V.: 2 (https://510kreport.com/company/philips-medical-systems-nederland)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Trillium Technology, Inc.: 1 (https://510kreport.com/company/trillium-technology)
- Siemens Medical Systems, Inc.: 1 (https://510kreport.com/company/siemens-medical-systems)
- Siemens AG Medical Solutions: 1 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Vida Diagnostics, Inc.: 1 (https://510kreport.com/company/vida-diagnostics)

## Its most-cited devices
- K071513: Inspace 4D Software Package with Extended Functionality (2007), cited by 5
- K043030: Magnetom C! MR System (2004), cited by 4
- K101749: Syngo Trued Software (2010), cited by 4
- K061671: Syngo Trued, Model VC10A (2006), cited by 2
- K060992: Syngo US Workplace (2006), cited by 2
- K233543: YSIO X.pree (2024), cited by 1

## Recent decisions
- K250738: YSIO X.pree (Jul 31, 2025)
- K250660: LUMINOS Q.namix T; LUMINOS Q.namix R (Jul 14, 2025)
- K233543: YSIO X.pree (May 21, 2024)
- K233532: MULTIX Impact E (Nov 29, 2023)
- K231577: MOBILETT Impact (Jul 25, 2023)
- K221281: Multitom Rax (Nov 17, 2022)
- K212212: Multitom Rax with True2scale Body Scan Option (Feb 18, 2022)
- K101749: Syngo Trued Software (Aug 16, 2010)

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