# Siemens Medical Solutions USA, Inc.

- Location (FDA's records): Iselin, NJ
- FDA decisions: 791 (1980–2026): 788 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Siemens Medical Solutions USA, Inc. (788); Siemens Medical Solutions U.S.A. (3)
- Product codes: LNH (135), JAK (106), IYN (75), LLZ (74), KPS (46), OWB (37), IYO (31), DSI (27), IYE (18), KPR (14), QIH (14), IZI (13)
- 510(k) review time since 2016: median 87 days, against 105 for FDA's reviews in the same codes and years (149 of 255 faster)
- Predicates its devices cite: 1,124 (742 its own); citations of its devices by later devices: 1,277 (742 its own)
- Recalls linked to its devices: 838 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medi Cal Solutions, Inc.: 51 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Siemens Medical Systems, Inc.: 50 (https://510kreport.com/company/siemens-medical-systems)
- Siemens Medical Solutions USA, Inc., Ultrasound DI: 15 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di)
- Siemens Corp.: 14 (https://510kreport.com/company/siemens)
- Siemens Elema AB: 14 (https://510kreport.com/company/siemens-elema)
- Siemens AG Medical Solutions: 14 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Siemens Medical Solution USA, Inc.: 12 (https://510kreport.com/company/siemens-medical-solution-usa)
- Acuson Corp.: 11 (https://510kreport.com/company/acuson)

## Firms that cite its devices most
- Draeger Medical Systems, Inc.: 36 (https://510kreport.com/company/draeger-medical-systems)
- Siemens Medi Cal Solutions, Inc.: 36 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Siemens Medical Solutions USA, Inc., Ultrasound DI: 19 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di)
- Siemens Medical Systems, Inc.: 19 (https://510kreport.com/company/siemens-medical-systems)
- Siemens Medical Solutions: 17 (https://510kreport.com/company/siemens-medical-solutions)
- Siemens Healthcare GmbH: 14 (https://510kreport.com/company/siemens-healthcare)
- Siemens AG Medical Solutions: 14 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Siemens Medical Solution USA, Inc.: 11 (https://510kreport.com/company/siemens-medical-solution-usa)

## Its most-cited devices
- K072786: Acuson S2000 Ultrasound System (2007), cited by 16
- K010938: Syngo Multimodality Workstation (2001), cited by 13
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F (2007), cited by 11
- K032428: Magnetom Avanto MR System (2003), cited by 11
- K062623: Axiom Luminos DRF (2007), cited by 10
- K971684: Magnetom Project 047 System (Numaris 3.5 Software) (1997), cited by 9

## Recent decisions
- K260055: syngo.CT Brain Quantification (Sep 25, 2026)
- K261696: ACUNAV Luxera 4D ICE Catheter (Sep 10, 2026)
- K260488: MULTIX Impact; MULTIX Impact C (Aug 31, 2026)
- K253786: syngo.CT Coronary Cockpit (Jun 25, 2026)
- K253678: MAMMOMAT B.brilliant (11372950) (Jun 18, 2026)
- K260844: ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (Jun 16, 2026)
- K261315: Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (May 21, 2026)
- K254184: syngo Application Software (Apr 29, 2026)

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