FDA 510(k)

Ablatherm 融合

K 號：K172285 · 2017-10-03

決定日期2017-10-03

產品代碼PLP

諮詢委員會GU

決定相當於

器材摘要

Ablatherm Fusion is the device name listed in this FDA 510(k) record. The listed applicant is Edap Technomed, Inc.. It received FDA 510(k) clearance on 2017-10-03 under 510(k) number K172285. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ablatherm Fusion?

Ablatherm Fusion is a medical device that received FDA 510(k) clearance on 2017-10-03. The listed applicant is Edap Technomed, Inc.. The 510(k) number is K172285.

When did Ablatherm Fusion receive FDA 510(k) clearance?

Ablatherm Fusion received FDA 510(k) clearance on 2017-10-03, under 510(k) number K172285.

Who is the listed applicant for Ablatherm Fusion?

The FDA 510(k) record lists Edap Technomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ablatherm Fusion?

The FDA product code for Ablatherm Fusion is PLP.

其他以 Edap Technomed, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251910Focal One®K172721FOCAL ONE

相關器械（代碼：PLP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251910Focal One®Edap Technomed, Inc.K240296塔斯卡普羅系統（Pad-105）Profound Medical, Inc.K231378Exablate 模型 2100V1，Exablate 前列腺系統，Exablate MRgFUS，Exablate 2100V1 型號 3.0Insightec, Ltd.K230692TULSA-PRO系統Profound Medical, Inc.K211858TULSA-PRO系統Profound Medical, Inc.K212150Exablate Prostate SystemInsightec, Inc.

官方來源

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