FDA 510(k)

HyperVue™影像系統 - 集成

K 號：K253101 · 2025-12-15

決定日期2025-12-15

產品代碼NQQ

諮詢委員會RA

決定相當於

器材摘要

HyperVue™ Imaging System - Integrated is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K253101. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HyperVue™ Imaging System - Integrated?

HyperVue™ Imaging System - Integrated is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Spectrawave, Inc.. The 510(k) number is K253101.

When did HyperVue™ Imaging System - Integrated receive FDA 510(k) clearance?

HyperVue™ Imaging System - Integrated received FDA 510(k) clearance on 2025-12-15, under 510(k) number K253101.

Who is the listed applicant for HyperVue™ Imaging System - Integrated?

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

What is the FDA product code for HyperVue™ Imaging System - Integrated?

The FDA product code for HyperVue™ Imaging System - Integrated is NQQ.

其他以 Spectrawave, 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。

K251355X1-FFR K251198HyperVue™ 軟體 K243016星光內視鏡導管 K230691HyperVue™影像系統 K221257SpectraWAVE影像系統

相關器械（代碼：NQQ）

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。

K253459OPTIS Mobile Next影像系統（1014932）；OPTIS整合型Next影像系統（1014933）；Ultreon 3.0軟體升級套件（ULTR300001）ABBOTT MEDICAL K251730LIA Console (542-7)Leadoptik, Inc.K252851deepLive (OSP12 + DMS)Damae Medical K251198HyperVue™ 軟體Spectrawave, Inc.K250684OPUSWAVE雙感測器成像系統Terumo Cardiovascular Systems Thi Plant K242924OPXION光學皮膚檢視器（OPXSV1-01F）Opxion Technology, Inc.

官方來源

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