FDA 510(k)

1788 4K 相機系統配先進成像技術；L12 LED 光源配 AIM

K 號：K231854 · 2023-09-20

決定日期2023-09-20

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K231854. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Stryker. The 510(k) number is K231854.

When did 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM receive FDA 510(k) clearance?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM received FDA 510(k) clearance on 2023-09-20, under 510(k) number K231854.

Who is the listed applicant for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

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

What is the FDA product code for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

The FDA product code for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is OWN.

其他以 Stryker 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。

K230416Triathlon® 鍵節膝關節系統；Triathlon® 修復插片 X3®K230754L12 LED光源配AIM K2306051788 4K 相機系統配先進成像技術 K2302161688 4K 鏡頭控制單元，具有先進影像技術 (1688010000)K2221301688 4K 鏡頭系統，具有先進影像技術 K220731Insignia 髋關節頭，Restoration 模組化 115mm 間接端頭

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相關器械（代碼：OWN）

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。

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG K254180PerfusiX-影像LIMIS Development B.V.K242163智能手術視覺系統SmartsurgN, Inc.K254242KARL STORZ ICG影像系統搭配RUBINA®鏡頭Karl Storz SE & CO. KG K251852cCeLL - 適用於In vivo與Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED光源配AIMStryker Endoscopy

官方來源

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