FDA 510(k)

Planmeca Romexis

K 號：K171385 · 2017-11-14

決定日期2017-11-14

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Planmeca Romexis is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2017-11-14 under 510(k) number K171385. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Planmeca Romexis?

Planmeca Romexis is a medical device that received FDA 510(k) clearance on 2017-11-14. The listed applicant is Planmeca Oy. The 510(k) number is K171385.

When did Planmeca Romexis receive FDA 510(k) clearance?

Planmeca Romexis received FDA 510(k) clearance on 2017-11-14, under 510(k) number K171385.

Who is the listed applicant for Planmeca Romexis?

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

What is the FDA product code for Planmeca Romexis?

The FDA product code for Planmeca Romexis is LLZ.

其他以 Planmeca Oy 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。

K230985Planmeca Viso K200572Planmeca Romexis K181576Planmeca Viso K160506Planmeca ProMax 3D Max, Planmeca Maximity 医療設備規範文本 Planmeca ProMax 3D Max, Planmeca Maximity 医療設備之規範文本 (注意：此處未進行完整的翻譯，僅提供翻譯範例，具體翻譯內容可能需要根據實際規範文本進行調整。)

相關器械（代碼：LLZ）

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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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