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FDA 510(k)

Leksell Gamma Knife Icon

K-Number: K160440 · 2016-04-20

ApplicantElekta Instrument AB
Decision Date2016-04-20
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Leksell Gamma Knife Icon is a medical device manufactured by Elekta Instrument AB. It received FDA 510(k) clearance on 2016-04-20 under approval number K160440. 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 Icon?

Leksell Gamma Knife Icon is a medical device that received FDA 510(k) clearance on 2016-04-20. It is manufactured by Elekta Instrument AB. The 510(k) number is K160440.

When was Leksell Gamma Knife Icon approved by the FDA?

Leksell Gamma Knife Icon received FDA 510(k) clearance on 2016-04-20, under approval number K160440.

What company makes Leksell Gamma Knife Icon?

Leksell Gamma Knife Icon is manufactured by Elekta Instrument AB.

What is the FDA product code for Leksell Gamma Knife Icon?

The FDA product code for Leksell Gamma Knife Icon 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 Instrument AB

K152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit K171123Leksell Vantage Stereotactic System K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173791Leksell GammaPlan K190887Leksell Vantage Stereotactic System

Related Devices (Code: IWB)

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. K200050Akesis Galaxy RTxAkesis, 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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