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Elekta Unity 1075900

by Elekta Inc.

Elekta Unity 1075900 is a Class II device made by Elekta Inc., listed in FDA GUDID since 30 Nov 2021 (UDI-DI 05060191071482), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060191071482 UDI-DI Date30 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Elekta Unity
Generic name
Linear accelerator system
Model / reference
1075900
Primary DI / UDI-DI
05060191071482
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

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)