Tae Young Soft Co., Ltd.
South KoreaFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Tae Young Soft Co., Ltd. makes
Tae Young Soft Co., Ltd. manufactures the ZeTTA PACS, a picture archiving and communication system (PACS) designed for digital medical imaging storage, retrieval, and distribution within healthcare settings.
The ZeTTA PACS is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) clearance pathway. The company is based in the United States.
Catalogue
- GUDID
ZeTTA PACS Ref K241694
510(k) 510(k)
Company details
- DUNS number
- 688401221
FDA establishments
- Taeyoung Soft Gwacheon-si Gyeonggi · KR FEI 3036758981
Frequently asked questions
How many devices does Tae Young Soft Co., Ltd. have in the registry?
The registry currently lists 2 devices for Tae Young Soft Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tae Young Soft Co., Ltd.'s devices?
Among its 2 most recently registered devices, Tae Young Soft 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 Tae Young Soft Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tae Young Soft Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tae Young Soft Co., Ltd. in the registry?
The most recently registered devices listed for Tae Young Soft Co., Ltd. include ZeTTA PACS.
Which FDA establishments are linked to Tae Young Soft Co., Ltd.?
1 FDA establishment is linked to Tae Young Soft Co., Ltd. in the registry; they are listed on the company page.