FDA 510(k)

Brainlab Elements – トラジェクトリ・プランニング（2.6）、Elements ステレオタキシ、Elements リード・ローカライゼーション、Elements トラジェクトリ・プランニング脳内

K番号: K223552 · 2023-04-19

決定日2023-04-19

製品コードHAW

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K223552. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial?

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Brainlab AG. The 510(k) number is K223552.

When did Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial receive FDA 510(k) clearance?

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial received FDA 510(k) clearance on 2023-04-19, under 510(k) number K223552.

Who is the listed applicant for Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial?

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

What is the FDA product code for Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial?

The FDA product code for Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial is HAW.

申請者としてBrainlab AGを記載するその他の記録

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252562脊椎・外傷ナビゲーション機器 K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD K243142頭蓋骨4Pi固定装置 K250440RT要素（4.5）；（要素）多発脳メトスSRS；（要素）頭蓋骨SRS；（要素）脊椎SRS；（要素）頭蓋骨SRS（コーン付き）；（要素）RT計画プラットフォーム；（要素）ドーズレビュー；（要素）再治療レビュー；（要素）セグメント[頭蓋骨、基底核、頭頸部、骨盤、脊椎、胸と脊椎、頭蓋外] RT；（要素）AI腫瘍セグメントRT；（要素）スマートブラッシュ[血管、脊椎] RT；（要素）オブジェクト管理RT K243633Brainlab Elements（7.0）；Brainlab Elements画像融合（5.0）；Brainlab Elements画像融合アンギオ（1.0）；Brainlab Elements形状描画（5.0）；Brainlab Elementsファイバートラッキング（3.0）；Brainlab Elements BOLD MRIマッピング（1.0）

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