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FDA 510(k)

NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS

K-Number: K984245 · 1998-12-18

ApplicantRadionics, Inc.
Decision Date1998-12-18
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1998-12-18 under 510(k) number K984245. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS?

NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS is a medical device that received FDA 510(k) clearance on 1998-12-18. The listed applicant is Radionics, Inc.. The 510(k) number is K984245.

When did NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS receive FDA 510(k) clearance?

NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS received FDA 510(k) clearance on 1998-12-18, under 510(k) number K984245.

Who is the listed applicant for NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS?

The FDA 510(k) record lists Radionics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS?

The FDA product code for NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS is HAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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