Aloka Co., Ltd.
Country not established
- Devices
- 41
What Aloka Co., Ltd. makes
Aloka Co., Ltd. manufactures diagnostic ultrasound systems, including standalone units like the SSD-3500, SSD-5500, and SSD-4000, as well as specialized transducers such as the UST-5258-5 and UST-665P-5. Their portfolio also includes data analysis systems like the DAS-RS1 and 3D ultrasound accessories for certain models. These devices are designed for medical imaging in diagnostic settings, supporting applications in obstetrics, cardiology, and general radiology.
The company’s ultrasound systems are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, adhering to FDA requirements for diagnostic imaging equipment. Aloka Co., Ltd. is based in the US.
Catalogue
Search and filter all 41 devicesFrequently asked questions
How many devices does Aloka Co., Ltd. have in the registry?
The registry currently lists 41 devices for Aloka Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aloka Co., Ltd.'s devices?
Among its 41 most recently registered devices, Aloka Co., Ltd. has devices listed in FDA 510(k) (41 devices).
What risk classes do Aloka Co., Ltd.'s devices fall under?
Among its 41 most recently registered devices, the classes recorded for Aloka Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aloka Co., Ltd. in the registry?
The most recently registered devices listed for Aloka Co., Ltd. include ALOKA SSD-3500 ULTRASOUND SYSTEM, ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 and ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER.