Medirune Co, Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Medirune Co, Ltd. makes
Medirune Co, Ltd. manufactures the I RUNE (I-200L), a device designed for intraoperative imaging and guidance in surgical procedures, likely supporting real-time visualization of anatomical structures or medical instruments.
The I RUNE (I-200L) is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
I Rune (I-200l) Ref K122410
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medirune Co, Ltd. have in the registry?
The registry currently lists 1 device for Medirune Co, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medirune Co, Ltd.'s devices?
Among its 1 most recently registered device, Medirune Co, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Medirune Co, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medirune Co, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medirune Co, Ltd. in the registry?
The most recently registered devices listed for Medirune Co, Ltd. include I RUNE (I-200L).