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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 the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2016-04-20 under 510(k) 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. The listed applicant is Elekta Instrument AB. The 510(k) number is K160440.

When did Leksell Gamma Knife Icon receive FDA 510(k) clearance?

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

Who is the listed applicant for Leksell Gamma Knife Icon?

The FDA 510(k) record lists Elekta Instrument AB as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Leksell Gamma Knife Icon is IWB.

Other records listing Elekta Instrument AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190887Leksell Vantage Stereotactic SystemK173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconK173791Leksell GammaPlanK171123Leksell Vantage Stereotactic SystemK152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit

Related Devices (Code: IWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, 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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