Skip to content

Rt Desktop

by Elekta Oncology Systems, Ltd.

510(k) K982713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK982713 Date2 Nov 1998ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1081-2014 FDA Class II initiated 25 Nov 2013

    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

    • Terminated Z-1555-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2007

    Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table.

    • Terminated Z-0421-2007 FDA Unclassified (pre-2012) initiated 23 Nov 2006

    Unexpected Diaphragm movement when manual field size modifications are not saved.

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  • Withdrawn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

Other devices from Elekta Oncology Systems, Ltd.