Ontact Health Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3044776706
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Ontact Health Co., Ltd. makes
Ontact Health Co., Ltd. manufactures the Sonix Health device, a medical imaging system designed for ultrasound-based diagnostic applications, including obstetrics, gynecology, and general radiology.
The Sonix Health device is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Sonix Health Ref K230209
Regimes: 510(k) Registry: 510(k)Sonix Health Ref K240645
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3044776706
- Address
- 184, Jungang-daero, Dong-gu, Busan
Frequently asked questions
How many devices does Ontact Health Co., Ltd. have in the registry?
The registry currently lists 2 devices for Ontact Health Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ontact Health Co., Ltd.'s devices?
Among its 2 most recently registered devices, Ontact Health Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ontact Health Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ontact Health Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ontact Health Co., Ltd. in the registry?
The most recently registered devices listed for Ontact Health Co., Ltd. include Sonix Health.