Insightech, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Insightech, Ltd. makes
Insightech, Ltd. manufactures the MRGFUS Pelvic PA Coil Model 1.0, a device designed for magnetic resonance-guided focused ultrasound (MRgFUS) procedures in the pelvic region.
This product is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Mrgfus Pelvic Pa Coil Model 1.0 Ref K111060
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insightech, Ltd. have in the registry?
The registry currently lists 1 device for Insightech, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insightech, Ltd.'s devices?
Among its 1 most recently registered device, Insightech, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Insightech, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Insightech, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Insightech, Ltd. in the registry?
The most recently registered devices listed for Insightech, Ltd. include MRGFUS PELVIC PA COIL MODEL 1.0.