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FDA 510(k)

LEKSELL GAMMAPLAN (LGP)

K-Number: K914808 · 1992-01-23

ApplicantElekta Instruments, Inc.
Decision Date1992-01-23
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 Instruments, Inc.. It received FDA 510(k) clearance on 1992-01-23 under 510(k) number K914808. 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 1992-01-23. The listed applicant is Elekta Instruments, Inc.. The 510(k) number is K914808.

When did LEKSELL GAMMAPLAN (LGP) receive FDA 510(k) clearance?

LEKSELL GAMMAPLAN (LGP) received FDA 510(k) clearance on 1992-01-23, under 510(k) number K914808.

Who is the listed applicant for LEKSELL GAMMAPLAN (LGP)?

The FDA 510(k) record lists Elekta Instruments, Inc. 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.

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Other records listing Elekta Instruments, Inc. 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.

K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEK955064SPETZLER TI 100 ANEURYSM CLIPK941823LEKSELL NEURO GENERATOR AND ACCESSORIESK946165CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEMK943468LEKSELL SURGIPLANK932261ES-100 ACCESSORIES

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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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