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FDA 510(k)

XKNIFE-3

K-Number: K953482 · 1995-10-25

ApplicantRadionics Software Applications, Inc.
Decision Date1995-10-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XKNIFE-3 is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1995-10-25 under 510(k) number K953482. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XKNIFE-3?

XKNIFE-3 is a medical device that received FDA 510(k) clearance on 1995-10-25. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K953482.

When did XKNIFE-3 receive FDA 510(k) clearance?

XKNIFE-3 received FDA 510(k) clearance on 1995-10-25, under 510(k) number K953482.

Who is the listed applicant for XKNIFE-3?

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

What is the FDA product code for XKNIFE-3?

The FDA product code for XKNIFE-3 is IYE.

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Other records listing Radionics Software Applications, Inc. as applicant

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Related Devices (Code: IYE)

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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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