Leksell GammaPlan (LGP)
K-Number: K232854 · 2024-02-08
ApplicantElekta Solutions AB
Decision Date2024-02-08
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Leksell GammaPlan (LGP) is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2024-02-08 under approval number K232854. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Leksell GammaPlan (LGP)?
Leksell GammaPlan (LGP) is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Elekta Solutions AB. The 510(k) number is K232854.
When was Leksell GammaPlan (LGP) approved by the FDA?
Leksell GammaPlan (LGP) received FDA 510(k) clearance on 2024-02-08, under approval number K232854.
What company makes Leksell GammaPlan (LGP)?
Leksell GammaPlan (LGP) is manufactured by Elekta Solutions AB.
What is the FDA product code for Leksell GammaPlan (LGP)?
The FDA product code for Leksell GammaPlan (LGP) is IWB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.