Digitalcore Co., Ltd.
JapanFDA applicant, unverified
- Devices
- 1
What Digitalcore Co., Ltd. makes
Digitalcore Co., Ltd. manufactures the ONIS-PACS, a picture archiving and communication system (PACS) designed for digital medical imaging storage, retrieval, and distribution in healthcare settings.
The ONIS-PACS system is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Onis-Pacs Ref K181318
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Digitalcore Co., Ltd. have in the registry?
The registry currently lists 1 device for Digitalcore Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Digitalcore Co., Ltd.'s devices?
Among its 1 most recently registered device, Digitalcore Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Digitalcore Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Digitalcore Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Digitalcore Co., Ltd. in the registry?
The most recently registered devices listed for Digitalcore Co., Ltd. include ONIS-PACS.