# Sumitomo Heavy Industries, Ltd.

- Location (FDA's records): Niihama, JP
- FDA decisions: 2 (2013–2016): 2 510(k) clearances
- Product codes: LHN (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Hitachi, Ltd., Power Systems Group: 1 (https://510kreport.com/company/hitachi-power-systems-group)
- Massachusetts General Hospital: 1 (https://510kreport.com/company/massachusetts-general-hospital)

## Its most-cited devices
- K130426: Sumitomo Proton Therapy System (2013), cited by 1

## Recent decisions
- K160612: Sumitomo Proton Therapy System (Aug 17, 2016)
- K130426: Sumitomo Proton Therapy System (Nov 19, 2013)

Source page: https://510kreport.com/company/sumitomo-heavy-industries