# Siemens Healthcare GmbH

- Location (FDA's records): Erlangen, DE
- FDA decisions: 32 (2016–2026): 32 510(k) clearances
- Names in FDA's records: Siemens Healthcare GmbH (31); Siemens Healthcare (1)
- Product codes: LLZ (14), QIH (5), JAK (3), OEB (2), LNH (2), QTZ (2), QKB (2), QDQ (1), IYN (1)
- 510(k) review time since 2016: median 105 days, against 131 for FDA's reviews in the same codes and years (18 of 28 faster)
- Predicates its devices cite: 39 (15 its own); citations of its devices by later devices: 38 (15 its own)
- Recalls linked to its devices: 3 (2 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.: 14 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Corp.: 3 (https://510kreport.com/company/siemens)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Screenpoint Medical B.V.: 1 (https://510kreport.com/company/screenpoint-medical)
- Siemens Medical Solutions USA, Inc. Ultrasound Group: 1 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-group)
- Philips Ultrasound, Inc.: 1 (https://510kreport.com/company/philips-ultrasound)
- Mirada Medical, Ltd.: 1 (https://510kreport.com/company/mirada-medical)
- Siemens AG Healthcare: 1 (https://510kreport.com/company/siemens-ag-healthcare)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 8 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Healthineers AG: 4 (https://510kreport.com/company/siemens-healthineers)
- Shanghai United Imaging Healthcare Co., Ltd.: 2 (https://510kreport.com/company/shanghai-united-imaging-healthcare)
- Clarius Mobile Health Corp.: 1 (https://510kreport.com/company/clarius-mobile-health)
- Coreline Soft Co., Ltd.: 1 (https://510kreport.com/company/coreline-soft)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Oxford Brain Diagnostics, Ltd.: 1 (https://510kreport.com/company/oxford-brain-diagnostics)
- Roclub GmbH: 1 (https://510kreport.com/company/roclub)

## Its most-cited devices
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems (2017), cited by 8
- K232744: syngo Virtual Cockpit (VB10A) (2023), cited by 4
- K230561: Syngo Carbon Space VA30A (2023), cited by 3
- K191040: syngo.via (Version VB40A) (2019), cited by 3
- K213706: AI-Rad Companion Brain MR (2022), cited by 2
- K203258: syngo.CT Lung CAD (2021), cited by 2

## Recent decisions
- K253264: myAblation Guide (VC10A) (Jun 16, 2026)
- K253689: syngo Dynamics (VA41F) (Apr 10, 2026)
- K252548: AI-Rad Companion Organs RT (Apr 10, 2026)
- K253057: AI-Rad Companion Brain MR (Jan 22, 2026)
- K252838: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise (Dec 19, 2025)
- K252608: AI-Rad Companion Prostate MR (Sep 9, 2025)
- K250443: MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (Jun 16, 2025)
- K242551: syngo Dynamics (Version VA41D) (Apr 3, 2025)

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