Insightec-Txsonics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Insightec-Txsonics, Inc. makes
Insightec-Txsonics, Inc. manufactures magnetic resonance-guided focused ultrasound (MRgFUS) coils, including a 1.5T MRgFUS pelvic coil and coils for general-purpose and breast applications. These devices are designed for non-invasive thermal ablation therapies, enabling precise tissue targeting under real-time MRI guidance.
The company’s products are classified as Class II devices under FDA regulations and are authorised via the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) registry. Insightec-Txsonics, Inc. is headquartered in the United States.
Catalogue
1.5T Mrgfus Pelvic Coil Ref K071966
Regimes: 510(k) Registry: 510(k)Mrgfus General Purpose And Breast Coil Ref K061715
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insightec-Txsonics, Inc. have in the registry?
The registry currently lists 2 devices for Insightec-Txsonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insightec-Txsonics, Inc.'s devices?
Among its 2 most recently registered devices, Insightec-Txsonics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Insightec-Txsonics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Insightec-Txsonics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Insightec-Txsonics, Inc. in the registry?
The most recently registered devices listed for Insightec-Txsonics, Inc. include 1.5T MRGFUS PELVIC COIL and MRGFUS GENERAL PURPOSE AND BREAST COIL.