Leksell GammaPlan
K-Number: K173791 · 2018-02-09
ApplicantElekta Instrument AB
Decision Date2018-02-09
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Leksell GammaPlan is a medical device manufactured by Elekta Instrument AB. It received FDA 510(k) clearance on 2018-02-09 under approval number K173791. 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?
Leksell GammaPlan is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Elekta Instrument AB. The 510(k) number is K173791.
When was Leksell GammaPlan approved by the FDA?
Leksell GammaPlan received FDA 510(k) clearance on 2018-02-09, under approval number K173791.
What company makes Leksell GammaPlan?
Leksell GammaPlan is manufactured by Elekta Instrument AB.
What is the FDA product code for Leksell GammaPlan?
The FDA product code for Leksell GammaPlan 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.