Cleared Traditional

Leksell GammaPlan (LGP)

K232854 · Elekta Solutions AB · Radiology
Feb 2024
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K232854 is an FDA 510(k) clearance for the Leksell GammaPlan (LGP), a System, Radiation Therapy, Radionuclide (Class II — Special Controls, product code IWB), submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on February 8, 2024, 146 days after receiving the submission on September 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5750.

Submission Details

510(k) Number K232854 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2023
Decision Date February 08, 2024
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWB — System, Radiation Therapy, Radionuclide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5750

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