# Siemens Medical Systems, Inc.

- Location (FDA's records): Mavern, PA
- FDA decisions: 25 (2001–2014): 25 510(k) clearances
- Product codes: JAK (14), OWB (1), KPR (1), MOS (1), OXO (1), IZI (1), DQK (1), LLZ (1), LNH (1), IYN (1), IZL (1), JAA (1)
- Predicates its devices cite: 34 (4 its own); citations of its devices by later devices: 79 (4 its own)
- Recalls linked to its devices: 62 (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.: 19 (https://510kreport.com/company/siemens-medical-solutions-usa)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Siemens AG Medical Solutions: 2 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Siemens Medical Corp.: 1 (https://510kreport.com/company/siemens-medical)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)
- Vida Diagnostics, Inc.: 1 (https://510kreport.com/company/vida-diagnostics)
- Prucka Engineering, Inc.: 1 (https://510kreport.com/company/prucka-engineering)
- Siemens Elema AB: 1 (https://510kreport.com/company/siemens-elema)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 50 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Medi Cal Solutions, Inc.: 4 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Sonosite,Inc.: 3 (https://510kreport.com/company/sonosite)
- Siemens Medical Solution USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solution-usa)
- Siemens AG Medical Solutions: 2 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Siemens Corp.: 2 (https://510kreport.com/company/siemens)
- Philips Medical Systems North America, Inc.: 2 (https://510kreport.com/company/philips-medical-systems-north-america)
- Omega Medical Imaging, Inc.: 2 (https://510kreport.com/company/omega-medical-imaging)

## Its most-cited devices
- K040970: Leonardo (2004), cited by 11
- K020353: Omnia X/XS Ultrasound System (2002), cited by 9
- K023687: Somatom Emotion 6 CT Systems (2002), cited by 6
- K120579: Somatom Definition Edge (2012), cited by 6
- K130901: Somatom Definition as Open (2014), cited by 6
- K013522: Somatom P30 CT Systems (2001), cited by 5

## Recent decisions
- K133646: Admire (Jun 20, 2014)
- K130901: Somatom Definition as Open (Jan 2, 2014)
- K123540: Syngo CT Pulmo 3D (Aug 29, 2013)
- K123541: Syngo.CT Neuro Perfusion (Apr 2, 2013)
- K122909: Syngo Single Source Dual Engery (Dec 27, 2012)
- K122471: Somatom Definition (Sep 11, 2012)
- K120579: Somatom Definition Edge (May 23, 2012)
- K121072: Somatom Definition Flash (May 8, 2012)

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