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Integrity™ 1526754

by Elekta Inc.

Integrity™ 1526754 is a Class II device made by Elekta Inc., cleared under FDA 510(k) K112613 on 16 Dec 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05060191071062), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K112613

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060191071062 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112613 Date16 Dec 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112613 decided 16 Dec 2011 Active
  • FDA GUDID UDI-DI 05060191071062 listed 24 Sep 2016 Listed

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

5 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. Listed FDA GUDID 05060191071062
  5. 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  • Withdrawn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

GUDID

Trade name
Integrity™
Generic name
Accelerator system computer
Model / reference
1526754
Primary DI / UDI-DI
05060191071062
510(k) Number
FDA product code
IYE
GMDN term
Accelerator system computer
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Accelerator system computer

Similar devices

Other devices filed under FDA product code IYE (Accelerator, linear, medical).

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See all devices from Elekta Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)