FDA 510(k)

StealthStation Synergy 頭部 S7 軟體 v.2.2.8，StealthStation 頭部軟體 v3.1.1

K 號：K190672 · 2019-07-31

決定日期2019-07-31

產品代碼HAW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190672. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K190672.

When did StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 receive FDA 510(k) clearance?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190672.

Who is the listed applicant for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

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

What is the FDA product code for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

The FDA product code for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is HAW.

其他以 Medtronic Navigation, Inc. 為申請人之記錄

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相關器械（代碼：HAW）

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。

K253856Geniant Cranial（導航神經外科定位機器人）Koh Young Technology, Inc.K261932萊克塞爾® Vantage 積極定位系統Elekta Solutions AB K253663Zeta導航系統Zeta Surgical, Inc.K253379Stealth AXiS 頭部臨床應用Medtronic Navigation, Inc.K231897神經對齊軟體Medivis, Inc.K251317SOLOPASS 2.0 系統Intravent Medical Partners

官方來源

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