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Integrity(Tm)

by Elekta Limited

510(k) K112613

Integrity(Tm) is a Class II device made by Elekta Limited, cleared under FDA 510(k) K112613 on 16 Dec 2011, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112613 Date16 Dec 2011ClearedStatusActive

Official records

Recalls

3 recalls · FDA

    • Terminated Z-0724-2018 FDA Class II initiated 20 Nov 2017

    Potential for positional errors following automatic table movement (ATM).

    • Terminated Z-1083-2014 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-1322-2014 FDA Class II initiated 28 Mar 2013

    The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

Timeline

4 dated events

  1. Cleared FDA 510(k) K112613
  2. Recall initiated FDA recalls Z-1322-2014
  3. Recall initiated FDA recalls Z-1083-2014
  4. Recall initiated FDA recalls Z-0724-2018

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K112613

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K112613
UDI-DISize and differences
Integrity™ 1526754
Elekta Inc.
152675405060191071062 —On the market

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