# Hitachi Aloka Medical America, Inc.

- Location (FDA's records): Wallingford, CT
- FDA decisions: 3 (2014–2016): 3 510(k) clearances
- Product codes: ITX (2), IYN (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hitachi Aloka Medical, Ltd.: 3 (https://510kreport.com/company/hitachi-aloka-medical)
- Hitachi Medical Systems America, Inc.: 1 (https://510kreport.com/company/hitachi-medical-systems-america)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Aloka Co., Ltd.: 1 (https://510kreport.com/company/aloka)

## Recent decisions
- K152126: Ust-5550-R; Ust-5536-R; L43K (Aug 17, 2016)
- K153421: HI Vision Ascendus, HV Ascendus, Ascendus (Jan 21, 2016)
- K142618: Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System (Oct 16, 2014)

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