Leksell GammaPlan— 510(k) K151666

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K151666 for Leksell GammaPlan, Substantially Equivalent on 2015-09-03. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2015-06-19
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

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More clearances from Elekta Instrument AB

K190887 — Leksell Vantage Stereotactic System2019-08-01
K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2018-03-30
K173791 — Leksell GammaPlan2018-02-09
K171123 — Leksell Vantage Stereotactic System2017-09-15
K160440 — Leksell Gamma Knife Icon2016-04-20

Recalls naming K151666

K-number listed on FDA's recall record

Z-1339-2026 — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.Class II·Ongoing·Elekta, Inc.·20251212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151666.

Data sourced from openFDA. This site is unofficial and independent of the FDA.