# Hitachi Aloka Medical, Ltd.

- Location (FDA's records): Wallingford, CT
- FDA decisions: 6 (2012–2015): 6 510(k) clearances
- Product codes: IYN (5), ITX (1)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 12 (2 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
- Hitachi Medical Systems America, Inc.: 2 (https://510kreport.com/company/hitachi-medical-systems-america)
- Aloka Co., Ltd.: 2 (https://510kreport.com/company/aloka)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical: 1 (https://510kreport.com/company/hitachi-aloka-medical-hitachi-aloka-medical)
- Aloka Co. Ltd USA: 1 (https://510kreport.com/company/aloka-co-usa)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Hudson Diagnostic Imaging, LLC: 1 (https://510kreport.com/company/hudson-diagnostic-imaging)

## Firms that cite its devices most
- Hitachi Aloka Medical America, Inc.: 3 (https://510kreport.com/company/hitachi-aloka-medical-america)
- Samsung Medison Co., Ltd.: 3 (https://510kreport.com/company/samsung-medison)
- Hitachi Medical Corp.: 1 (https://510kreport.com/company/hitachi-medical)
- Konica Minolta, Inc.: 1 (https://510kreport.com/company/konica-minolta)
- Hitachi, Ltd.: 1 (https://510kreport.com/company/hitachi)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical: 1 (https://510kreport.com/company/hitachi-aloka-medical-hitachi-aloka-medical)

## Its most-cited devices
- K142368: Noblus Diagnostic Ultrasound Scanner (2015), cited by 7
- K123828: Prosound F75 Diagnostic Ultrasound System (2013), cited by 2
- K130308: Noblus Ultrasound Diagnostic System (2013), cited by 1
- K140854: Intra-Operative Ultrasound Transducer (2014), cited by 1
- K140639: Prosound F75  Diagnostic Ultrasound System (2014), cited by 1

## Recent decisions
- K142368: Noblus Diagnostic Ultrasound Scanner (Jan 14, 2015)
- K140854: Intra-Operative Ultrasound Transducer (Jun 11, 2014)
- K140639: Prosound F75  Diagnostic Ultrasound System (Apr 16, 2014)
- K130308: Noblus Ultrasound Diagnostic System (Apr 5, 2013)
- K123828: Prosound F75 Diagnostic Ultrasound System (Jan 18, 2013)
- K122341: Prosound F37 Diagnostic Ultrasound System, Model: Prosound F37 (Sep 26, 2012)

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