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Apex™ 1526774

by Elekta Inc.

Apex 1526774 is a medical device (FDA Class II; FDA product code IXI, Block, beam-shaping, radiation therapy) made by Elekta Inc., cleared under FDA 510(k) K111676 on 30 Sep 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05060191071215), active as of 22 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K111676

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 Number05060191071215 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111676 Date30 Sep 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111676 decided 30 Sep 2011 Active
  • FDA GUDID UDI-DI 05060191071215 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0885-2013 FDA Class II initiated 18 Jan 2013

    If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

Timeline

3 dated events

  1. Cleared FDA 510(k) K111676
  2. Recall initiated FDA recalls Z-0885-2013
  3. Listed FDA GUDID 05060191071215

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Apex™
Generic name
Automatic-aperture-control accelerator system collimator
Model / reference
1526774
Primary DI / UDI-DI
05060191071215
510(k) Number
FDA product code
IXI
GMDN term
Automatic-aperture-control accelerator system collimator
Device class
Class II
Regulation number
892.5710
GUDID distribution status
In Commercial Distribution

Related devices

Category: Automatic-aperture-control accelerator system collimator

Similar devices

Other devices filed under FDA product code IXI (Block, beam-shaping, radiation therapy).

Other devices from Elekta Inc.

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    Class II

  • Elekta Unity 1536549

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  • 1525333

    Class II

  • 1525332

    Class II

See all devices from Elekta Inc. →

Properties

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