# Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical

- Location (FDA's records): Wallingford, CT
- FDA decisions: 3 (2013–2014): 3 510(k) clearances
- Product codes: IYN (3)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aloka Co., Ltd.: 2 (https://510kreport.com/company/aloka)
- Aloka Co. Ltd USA: 1 (https://510kreport.com/company/aloka-co-usa)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)
- Hitachi Aloka Medical, Ltd.: 1 (https://510kreport.com/company/hitachi-aloka-medical)

## Firms that cite its devices most
- Esaote, S.p.A.: 2 (https://510kreport.com/company/esaote)
- Hitachi, Ltd.: 2 (https://510kreport.com/company/hitachi)
- Endosound, Inc.: 1 (https://510kreport.com/company/endosound)
- Hitachi Aloka Medical, Ltd.: 1 (https://510kreport.com/company/hitachi-aloka-medical)
- Hitachi Healthcare Americas: 1 (https://510kreport.com/company/hitachi-healthcare-americas)

## Its most-cited devices
- K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner (2014), cited by 6
- K122537: Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0 (2013), cited by 1

## Recent decisions
- K140443: Arietta 60/ARIETTAS60/ARIETTAV60 (Jun 16, 2014)
- K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner (Mar 28, 2014)
- K122537: Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0 (Apr 12, 2013)

Source page: https://510kreport.com/company/hitachi-aloka-medical-hitachi-aloka-medical