# Siemens Healthineers AG

- Location (FDA's records): Forchheim, DE
- FDA decisions: 8 (2019–2026): 8 510(k) clearances
- Names in FDA's records: Siemens Healthineers AG (6); Siemens Healthineers (2)
- Product codes: LLZ (2), QIH (2), KPS (1), OUO (1), IYN (1), LNH (1)
- 510(k) review time since 2016: median 89 days, against 126 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (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.: 5 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Siemens Healthcare GmbH: 4 (https://510kreport.com/company/siemens-healthcare)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- E-Scopics: 1 (https://510kreport.com/company/e-scopics)

## Its most-cited devices
- K183575: ACUSON S3000, S2000 Diagnostic Ultrasound System (2019), cited by 3

## Recent decisions
- K263048: Syngo Carbon Space (VA4) (Sep 29, 2026)
- K260852: MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (Jul 31, 2026)
- K253690: LungMaps (Jun 15, 2026)
- K253023: BIOGRAPH One (Jan 15, 2026)
- K253495: syngo.MR Applications (VB80) (Nov 20, 2025)
- K251059: Syngo Carbon Clinicals (VA41) (Oct 24, 2025)
- K241898: Symbia SPECT and SPECT/CT Systems (Jul 26, 2024)
- K183575: ACUSON S3000, S2000 Diagnostic Ultrasound System (Mar 20, 2019)

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