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FDA 510(k)

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

K-Number: K250391 · 2025-07-02

ApplicantElekta Solutions AB
Decision Date2025-07-02
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2025-07-02 under approval number K250391. 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 Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Elekta Solutions AB. The 510(k) number is K250391.

When was Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) approved by the FDA?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) received FDA 510(k) clearance on 2025-07-02, under approval number K250391.

What company makes Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is manufactured by Elekta Solutions AB.

What is the FDA product code for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)?

The FDA product code for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) is IWB.

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Elekta Solutions AB

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Related Devices (Code: IWB)

K160440Leksell Gamma Knife IconElekta Instrument AB K172706GammaPod - Model AXcision Medical Systems, LLC K180571GammaPodXcision Medical Systems, LLC K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB K173791Leksell GammaPlanElekta Instrument AB K190844Akesis GalaxyAkesis, Inc.

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.

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