FDA 510(k)

智能縫合軟體系統，圖像處理，放射學

K 號：K163048 · 2017-07-28

決定日期2017-07-28

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Smart Stitching Software System, Image Processing, Radiological is the device name listed in this FDA 510(k) record. The listed applicant is Osko, Inc.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K163048. 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 Smart Stitching Software System, Image Processing, Radiological?

Smart Stitching Software System, Image Processing, Radiological is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Osko, Inc.. The 510(k) number is K163048.

When did Smart Stitching Software System, Image Processing, Radiological receive FDA 510(k) clearance?

Smart Stitching Software System, Image Processing, Radiological received FDA 510(k) clearance on 2017-07-28, under 510(k) number K163048.

Who is the listed applicant for Smart Stitching Software System, Image Processing, Radiological?

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

What is the FDA product code for Smart Stitching Software System, Image Processing, Radiological?

The FDA product code for Smart Stitching Software System, Image Processing, Radiological is LLZ.

其他以 Osko, 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。

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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。

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