# Siemens Medical Solution USA, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 11 (2004–2022): 11 510(k) clearances
- Names in FDA's records: Siemens Medical Solution USA, Inc. (8); Siemens Medical Solution, Inc. USA (3)
- Product codes: OWB (3), LLZ (3), JAK (2), LNH (1), KPS (1), MOS (1)
- 510(k) review time since 2016: median 85 days, against 74 for FDA's reviews in the same codes and years (1 of 8 faster)
- Predicates its devices cite: 17 (3 its own); citations of its devices by later devices: 20 (3 its own)
- Recalls linked to its devices: 86 (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.: 11 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Medical Systems, Inc.: 2 (https://510kreport.com/company/siemens-medical-systems)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 12 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Epica International, Inc.: 1 (https://510kreport.com/company/epica-international)
- Siemens Medical Systems USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-systems-usa)
- GE Medical Systems SCS: 1 (https://510kreport.com/company/ge-medical-systems-scs)
- Mediso Medical Imaging Systems, Ltd.: 1 (https://510kreport.com/company/mediso-medical-imaging-systems)
- 4Dx Limited: 1 (https://510kreport.com/company/4dx)

## Its most-cited devices
- K181407: Artis zee/zeego & Artis Q/Q.zen (2018), cited by 6
- K163286: ARTIS pheno (2017), cited by 4
- K050297: Somatom Emotion 16 (2005), cited by 4
- K193178: Biograph Horizon (2020), cited by 2
- K190780: syngo Application Software (2019), cited by 1
- K163285: syngo Application Software (2017), cited by 1

## Recent decisions
- K220433: syngo Application Software (VE21) (Aug 16, 2022)
- K201156: ARTIS pheno (VE2) (Jun 29, 2020)
- K193178: Biograph Horizon (Feb 12, 2020)
- K190780: syngo Application Software (Sep 12, 2019)
- K190757: MAGNETOM Avanto Fit (May 31, 2019)
- K181407: Artis zee/zeego & Artis Q/Q.zen (Aug 15, 2018)
- K163286: ARTIS pheno (Mar 9, 2017)
- K163285: syngo Application Software (Feb 14, 2017)

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