Leksell GammaPlan 1551287

by Elekta Instrument AB

Leksell GammaPlan 1551287 is a Class II device made by Elekta Instrument AB, listed in FDA GUDID since 13 Jun 2020 (UDI-DI 07340048311878), registry data as of 23 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07340048311878 UDI-DI	Date13 Jun 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 07340048311878

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Leksell GammaPlan
Generic name: Stereotactic system application software
Model / reference: 1551287

Primary DI / UDI-DI: 07340048311878
FDA product code: MUJ, IWB
GMDN term: Stereotactic system application software

Device class: Class II
Regulation number: 892.5050, 892.5750
GUDID distribution status: In Commercial Distribution

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Properties

Other properties (15, all answered No)