# Hitachi, Ltd.

- Location (FDA's records): Wallingford, CT
- FDA decisions: 8 (2006–2020): 8 510(k) clearances
- Product codes: LHN (4), IYN (3), MOT (1)
- 510(k) review time since 2016: median 79 days, against 74 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hitachi, Ltd., Health Care Company: 3 (https://510kreport.com/company/hitachi-health-care)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical: 2 (https://510kreport.com/company/hitachi-aloka-medical-hitachi-aloka-medical)
- Hitachi, Ltd., Power Systems Group: 1 (https://510kreport.com/company/hitachi-power-systems-group)
- Rad Source Technologies, Inc.: 1 (https://510kreport.com/company/rad-source-technologies)
- Mds Nordion: 1 (https://510kreport.com/company/mds-nordion)
- Hitachi Aloka Medical, Ltd.: 1 (https://510kreport.com/company/hitachi-aloka-medical)

## Firms that cite its devices most
- R3 X-Ray L.L.C: 1 (https://510kreport.com/company/r3-x-ray)
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha: 1 (https://510kreport.com/company/hitachi-radiation-oncology-systems-kashiwanoha)
- Hitachi, Ltd., Power Systems Group: 1 (https://510kreport.com/company/hitachi-power-systems-group)
- Hitachi High-Tech Corp.: 1 (https://510kreport.com/company/hitachi-high-tech)

## Its most-cited devices
- K201042: Probeat-CR (2020), cited by 2
- K191801: Probeat-CR (2019), cited by 1
- K060834: Probeat with MGCS (2006), cited by 1
- K172087: Sangray (2017), cited by 1

## Recent decisions
- K201042: Probeat-CR (Jul 13, 2020)
- K191801: Probeat-CR (Sep 13, 2019)
- K172087: Sangray (Oct 27, 2017)
- K163505: Arietta Precision (May 30, 2017)
- K162902: ARIETTA Prologue Diagnostic Ultrasound system and Transducers (Dec 15, 2016)
- K162583: Aloka Lisendo 880 (Nov 17, 2016)
- K161163: PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory (Jul 13, 2016)
- K060834: Probeat with MGCS (Apr 19, 2006)

Source page: https://510kreport.com/company/hitachi