Non-Invasive Dynamic Reference Frame (DRF) for Optical Tracking System, Model Ots
FDA 510(k) K984245 · Radionics, Inc.
510(k) numberK984245
Submission
- Device name
- Non-Invasive Dynamic Reference Frame (DRF) for Optical Tracking System, Model Ots
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- November 27, 1998
- Decision date
- December 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Non-Invasive Dynamic Reference Frame (DRF) for Optical Tracking System, Model Ots cleared by the FDA?
Non-Invasive Dynamic Reference Frame (DRF) for Optical Tracking System, Model Ots (K984245) received a 510(k) decision of Substantially Equivalent on December 18, 1998, 21 days after the submission was received.
What is the product code of K984245?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.