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Radionics Software Applications, Inc.

United StatesFDA applicant, unverified

Devices
12

What Radionics Software Applications, Inc. makes

Radionics Software Applications, Inc. manufactures optical tracking systems for surgical navigation, including the Optical Tracking System Microscope Module II and standalone Optical Tracking System (OTS), which align imaging and procedural tools in real time. Their portfolio also includes the X-Knife-3 for radiosurgery, the Stereoplan for surgical planning, and the Operating Arm System (OAS) with CT/MR image integration for precise robotic-assisted procedures. Additional offerings include the ImageFusion system for multimodal image alignment, the XPlan-1 for surgical planning, and the Gill-Thomas-Cosman (GTC) dental tray for stereotactic radiosurgery applications.

The company’s devices are classified under Class II by the FDA and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

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  • Optical Tracking System Microscope Module Ii, Model Ots Mmii Ref K990326

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Xknife-3 Ref K953482

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Stereoplan Ref K946252

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Linac-Based Sterotactic Radiosurgery Ref K923522

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optical Tracking System (Ots) Ref K964801

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Operating Arm System (Oas) [With Ct And Mr Images] Ref K961844

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Operating Arm System (Oas) Ref K951262

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imagefusion Ref K960071

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optical Tracking System (Ots) Ref K974602

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gill-Thomas-Cosman(Gtc) Dental Tray Ref K962155

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Xplan-1 Ref K972905

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Crw-1 System Ref K944463

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-12 of 12

Frequently asked questions

How many devices does Radionics Software Applications, Inc. have in the registry?

The registry currently lists 12 devices for Radionics Software Applications, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Radionics Software Applications, Inc.'s devices?

Among its 12 most recently registered devices, Radionics Software Applications, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Radionics Software Applications, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Radionics Software Applications, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Radionics Software Applications, Inc. in the registry?

The most recently registered devices listed for Radionics Software Applications, Inc. include OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII, XKNIFE-3, STEREOPLAN and LINAC-BASED STEROTACTIC RADIOSURGERY.

Generated automatically from registry data and not verified by a human reviewer.