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Elekta Unity 1065120

by Elekta Inc.

Elekta Unity 1065120 is a Class II device made by Elekta Inc., cleared under FDA 510(k) K182076 on 4 Dec 2018 and listed in FDA GUDID since 30 Apr 2019 (UDI-DI 05060191071437), active as of 22 Oct 2026. 4 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

4 closed

Documents

510(k) K182076

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 Number05060191071437 UDI-DI Date30 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182076 Date4 Dec 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182076 decided 4 Dec 2018 Active
  • FDA GUDID UDI-DI 05060191071437 listed 30 Apr 2019 Listed

Recalls

4 recalls · FDA

    • Terminated Z-1980-2019 FDA Class II initiated 24 Jun 2019

    The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.

    • Terminated Z-1297-2019 FDA Class II initiated 3 Apr 2019

    There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.

    • Terminated Z-1109-2019 FDA Class II initiated 12 Mar 2019

    Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.

    • Completed Z-0706-2019 FDA Class II initiated 4 Jan 2019

    In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

Timeline

6 dated events

  1. Cleared FDA 510(k) K182076
  2. Recall initiated FDA recalls Z-0706-2019
  3. Recall initiated FDA recalls Z-1109-2019
  4. Recall initiated FDA recalls Z-1297-2019
  5. Listed FDA GUDID 05060191071437
  6. Recall initiated FDA recalls Z-1980-2019

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Elekta Unity
Generic name
Linear accelerator system
Model / reference
1065120
Primary DI / UDI-DI
05060191071437
510(k) Number
FDA product code
IYE
GMDN term
Linear accelerator system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Linear accelerator system

Cleared under the same submission (K182076)

Other devices from Elekta Inc.

  • XVI 1526927

    Class II

  • Elekta Unity 1536549

    Class II

  • 1525333

    Class II

  • 1525332

    Class II

See all devices from Elekta Inc. →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)