Integra Radionics, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Integra Radionics, Inc. makes
The company manufactures ultrasonic surgical aspirators and accessories, including shear tips, extended-length tips, and bone tips for tissue ablation systems, as well as image-guided radiosurgery devices like the XKnife systems for precise cranial and spinal interventions. Additional products include collimator assemblies for linear accelerators and patient adapters for radiosurgical procedures.
These devices are classified under FDA Class II and Class U, with regulatory authorisation supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) registry, and the company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Integra Radionics Imagefusion 3 Ref K063230
Regimes: 510(k) Registry: 510(k)Radionics Xknife Hdrt System Ref K083414
Regimes: 510(k) Registry: 510(k)Integra Radionics Xknife Rt 4 Ref K061893
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Xknife 5 Ref K100417
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Integra Radionics Interfix Patient Adapters Ref K072454
Regimes: 510(k) Registry: 510(k)Cusa Nxt Extended Length Tip Ref K102258
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Integra Radionics, Inc. have in the registry?
The registry currently lists 10 devices for Integra Radionics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integra Radionics, Inc.'s devices?
Among its 10 most recently registered devices, Integra Radionics, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Integra Radionics, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Integra Radionics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Integra Radionics, Inc. in the registry?
The most recently registered devices listed for Integra Radionics, Inc. include CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM, INTEGRA RADIONICS IMAGEFUSION 3, RADIONICS XKNIFE HDRT SYSTEM and INTEGRA RADIONICS XKNIFE RT 4.