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Radionics, Inc.

United StatesFDA applicant, unverified

Devices
56
FDA recalls
1

What Radionics, Inc. makes

Radionics, Inc. manufactures disposable radiofrequency (RF) cannulae for surgical procedures, including variants for specific applications like the SC-C and RFK-DB models. Their portfolio includes medical imaging tools such as the Ocular-Biometer 4000 for eye measurements and the Slice Editor imaging software utility for medical imaging refinement. Additionally, they produce cardiac devices like the PACE-1A cardiac stimulator and the Ojemann Cortical Stimulator for neurosurgical applications, as well as specialized surgical instruments such as the Burr Hole Valve and Linac couch-mount systems for radiation therapy. The company also supplies catheter passers for vascular procedures and depth electrode kits for neurological assessments.

The company’s devices are classified under FDA categories Class I and Class II, with several products listed via the 510(k) pathway. These regulatory designations apply to medical instruments, imaging tools, and surgical implants used in ophthalmology, cardiology, neurosurgery, and radiation therapy. Radionics, Inc. is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

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FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Radionics, Inc., initiated on 2004-05-25. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 25 May 2004 Z-1020-04 Unclassified (pre-2012) Terminated Software may provide inaccurate coordinates and cause mistreatment Distribution: Canada, Germany, Greece Submission number: K991237