FDA 510(k)

AIBOLIT 3D+

K 號：K211443 · 2022-01-07

決定日期2022-01-07

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

AIBOLIT 3D+ is the device name listed in this FDA 510(k) record. The listed applicant is Aibolit Technologies, LLC. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211443. 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 AIBOLIT 3D+?

AIBOLIT 3D+ is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Aibolit Technologies, LLC. The 510(k) number is K211443.

When did AIBOLIT 3D+ receive FDA 510(k) clearance?

AIBOLIT 3D+ received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211443.

Who is the listed applicant for AIBOLIT 3D+?

The FDA 510(k) record lists Aibolit Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIBOLIT 3D+?

The FDA product code for AIBOLIT 3D+ is LLZ.

其他以 Aibolit Technologies, LLC 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。

K222458AIBOLIT 3D+

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。