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Xknife Radiosurgery System

by Rsa, Inc.

510(k) K912630

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912630 Date4 Nov 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Xknife Radiosurgery System is a medical accelerator device classified under product code IYE and regulation number 892.5050. It is a substantially equivalent device cleared through the traditional 510(k) pathway, with decision date November 4, 1991, and is used in the field of radiology.

The system is manufactured by Rsa, Inc. and is supplied as a Class II medical device. It has received FDA 510(k) clearance under K912630 and is intended for use in radiology settings. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorisations is provided in the data.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Xknife Radiosurgery System used for?

    The Xknife Radiosurgery System is intended for use in radiology settings as a medical accelerator device, based on its classification under product code IYE and regulation number 892.5050, and its clearance for radiology applications.

  • How is the Xknife Radiosurgery System supplied and what is its regulatory classification?

    The Xknife Radiosurgery System is supplied as a Class II medical device and received FDA 510(k) clearance under K912630 through the traditional pathway, with a decision date of November 4, 1991, confirming its substantially equivalent status.

  • Is the Xknife Radiosurgery System sterile or designed for single-use?

    The provided data does not include any information regarding the sterility, single-use, or reusable status of the Xknife Radiosurgery System, so these details cannot be determined from the available specifications.

  • What sizes or models are available for the Xknife Radiosurgery System?

    No specific sizes, models, or reference numbers beyond the device name 'Xknife Radiosurgery System' are provided in the data, so no details about sizing or model variations can be confirmed.

  • What are the storage requirements for the Xknife Radiosurgery System?

    The device data does not contain any information about storage conditions, temperature requirements, or environmental storage specifications for the Xknife Radiosurgery System.