Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical
Country not established
- Devices
- 3
What Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical makes
The company manufactures diagnostic ultrasound scanners, including the ARIETTA 70, ARIETTA S70, ARIETTA V70, ARIETTA 60, and PROSOUND ALPHA 7 (Ver. 6.0). These systems are designed for medical imaging, supporting applications such as obstetrics, cardiology, and general radiology.
The portfolio consists of Class II medical devices, with models authorised via the FDA’s 510(k) pathway. The company is based in the United States and its devices are listed under the relevant regulatory registries for Class II ultrasound systems.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Arietta 60/ARIETTAS60/ARIETTAV60 Ref K140443
Regimes: 510(k) Registry: 510(k)Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0 Ref K122537
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical have in the registry?
The registry currently lists 3 devices for Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical's devices?
Among its 3 most recently registered devices, Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical has devices listed in FDA 510(k) (3 devices).
What risk classes do Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical in the registry?
The most recently registered devices listed for Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical include ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER, ARIETTA 60/ARIETTAS60/ARIETTAV60 and PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0.