Oncosoft. Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 2
What Oncosoft. Co., Ltd. makes
Oncosoft Co., Ltd. manufactures OncoStudio (OS-01), a medical device designed for oncology-related diagnostic or treatment support, including imaging analysis or treatment planning software.
OncoStudio (OS-01) is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
OncoStudio (OS-01) Ref K242994
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 695660677
Frequently asked questions
How many devices does Oncosoft. Co., Ltd. have in the registry?
The registry currently lists 2 devices for Oncosoft. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oncosoft. Co., Ltd.'s devices?
Among its 2 most recently registered devices, Oncosoft. Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Oncosoft. Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Oncosoft. Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oncosoft. Co., Ltd. in the registry?
The most recently registered devices listed for Oncosoft. Co., Ltd. include OncoStudio 2.0.x and OncoStudio (OS-01).