Given Imaging Ltd. (Medtronic)
IsraelFDA applicant, unverified
- Devices
- 2
What Given Imaging Ltd. (Medtronic) makes
Given Imaging Ltd. (Medtronic) manufactures capsule endoscopy systems, including the PillCam SB 3 with accompanying software (version 9.0E). These devices enable non-invasive visualization of the small bowel by capturing images as the capsule passes through the digestive tract.
The capsule endoscopy systems fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Given Imaging Ltd. (Medtronic) have in the registry?
The registry currently lists 2 devices for Given Imaging Ltd. (Medtronic). Devices recorded under merged duplicate company entries are counted once.
Which registries list Given Imaging Ltd. (Medtronic)'s devices?
Among its 2 most recently registered devices, Given Imaging Ltd. (Medtronic) has devices listed in FDA 510(k) (2 devices).
What risk classes do Given Imaging Ltd. (Medtronic)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Given Imaging Ltd. (Medtronic)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Given Imaging Ltd. (Medtronic) in the registry?
The most recently registered devices listed for Given Imaging Ltd. (Medtronic) include PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E.