Hitachi Aloka Medical, Ltd.
Country not established
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Hitachi Aloka Medical, Ltd. makes
The company manufactures diagnostic ultrasound systems, including the ProSound F37, ProSound F75, and Noblus series, as well as intra-operative ultrasound transducers. These devices are designed for medical imaging to assist in diagnostic and surgical procedures.
The portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) pathway. These products are listed under U.S. regulatory requirements and are based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Prosound F75 Diagnostic Ultrasound System Ref K123828
Regimes: 510(k) Registry: 510(k)Prosound F75 Diagnostic Ultrasound System Ref K140639
Regimes: 510(k) Registry: 510(k)Noblus Diagnostic Ultrasound Scanner Ref K142368
Regimes: 510(k) Registry: 510(k)Noblus Ultrasound Diagnostic System Ref K130308
Regimes: 510(k) Registry: 510(k)Intra-Operative Ultrasound Transducer Ref K140854
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Hitachi Aloka Medical, Ltd., initiated on 2014-06-11. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 11 Jun 2014 Z-1696-2017 Class II Terminated Loosened monitor arm.
Frequently asked questions
How many devices does Hitachi Aloka Medical, Ltd. have in the registry?
The registry currently lists 6 devices for Hitachi Aloka Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hitachi Aloka Medical, Ltd.'s devices?
Among its 6 most recently registered devices, Hitachi Aloka Medical, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Hitachi Aloka Medical, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Hitachi Aloka Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hitachi Aloka Medical, Ltd.?
FDA recall records list 1 recall initiated by Hitachi Aloka Medical, Ltd., the most recent initiated on 11 Jun 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Hitachi Aloka Medical, Ltd. in the registry?
The most recently registered devices listed for Hitachi Aloka Medical, Ltd. include PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37, PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM, NOBLUS DIAGNOSTIC ULTRASOUND SCANNER and NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM.