FDA 510(k)

優化定位系統 (OPS) Insight

K 號：K192656 · 2020-05-01

決定日期2020-05-01

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Optimized Positioning System (OPS) Insight is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192656. 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 Optimized Positioning System (OPS) Insight?

Optimized Positioning System (OPS) Insight is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Corin USA. The 510(k) number is K192656.

When did Optimized Positioning System (OPS) Insight receive FDA 510(k) clearance?

Optimized Positioning System (OPS) Insight received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192656.

Who is the listed applicant for Optimized Positioning System (OPS) Insight?

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

What is the FDA product code for Optimized Positioning System (OPS) Insight?

The FDA product code for Optimized Positioning System (OPS) Insight is LLZ.

其他以 Corin USA 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。

K203751OMNIVision系統 K202805優化定位系統 (OPS) Insight K193545Corin最佳定位系統 (OPS) 髋部 K193042優化定位系統（OPS）檢視 K190143LARS AC 電帶設備 K190834Corin最佳定位系統功能髋關節分析（OPS FHA）

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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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