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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2024-02-08 under 510(k) 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. The listed applicant is Elekta Solutions AB. The 510(k) number is K232854.

When did Leksell GammaPlan (LGP) receive FDA 510(k) clearance?

Leksell GammaPlan (LGP) received FDA 510(k) clearance on 2024-02-08, under 510(k) number K232854.

Who is the listed applicant for Leksell GammaPlan (LGP)?

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

What is the FDA product code for Leksell GammaPlan (LGP)?

The FDA product code for Leksell GammaPlan (LGP) is IWB.

Other records listing Elekta Solutions 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.

K261932Leksell® Vantage Stereotactic SystemK252002Monaco RTP System (6.3)K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)K251363ProKnow DSK250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)K223233Monaco RTP System

View all 15 devices →

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 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.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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