Hitachi Aloka Medical America, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Hitachi Aloka Medical America, Inc. makes
Hitachi Aloka Medical America, Inc. manufactures diagnostic ultrasound systems, including the HI VISION ASCENDUS, PROSOUND ALPHA 7, and ARIETTA 70 models. The company also produces various ultrasound transducers, such as the UST-5550-R, UST-5536-R, and L43K, designed for clinical and intra-operative imaging applications.
The company is based in the United States, and its portfolio consists of Class II medical devices. These products are documented in the FDA 510(k) registry.
Catalogue
Hi Vision Ascendus, Hv Ascendus, Ascendus Ref K153421
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ust-5550-R; Ust-5536-R; L43K Ref K152126
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hitachi Aloka Medical America, Inc. have in the registry?
The registry currently lists 3 devices for Hitachi Aloka Medical America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hitachi Aloka Medical America, Inc.'s devices?
Among its 3 most recently registered devices, Hitachi Aloka Medical America, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Hitachi Aloka Medical America, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hitachi Aloka Medical America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hitachi Aloka Medical America, Inc. in the registry?
The most recently registered devices listed for Hitachi Aloka Medical America, Inc. include HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS, Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System and UST-5550-R; UST-5536-R; L43K.