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FDA 510(k)

XKNIFE RADIOSURGERY SYSTEM

K-Number: K912630 · 1991-11-04

ApplicantRsa, Inc.
Decision Date1991-11-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XKNIFE RADIOSURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rsa, Inc.. It received FDA 510(k) clearance on 1991-11-04 under 510(k) number K912630. 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 RADIOSURGERY SYSTEM?

XKNIFE RADIOSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-04. The listed applicant is Rsa, Inc.. The 510(k) number is K912630.

When did XKNIFE RADIOSURGERY SYSTEM receive FDA 510(k) clearance?

XKNIFE RADIOSURGERY SYSTEM received FDA 510(k) clearance on 1991-11-04, under 510(k) number K912630.

Who is the listed applicant for XKNIFE RADIOSURGERY SYSTEM?

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

What is the FDA product code for XKNIFE RADIOSURGERY SYSTEM?

The FDA product code for XKNIFE RADIOSURGERY SYSTEM is IYE.

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Official Source

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

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