FDA 510(k)

瑞輝olve

K 號：K260378 · 2026-05-12

申請人AZmed

決定日期2026-05-12

產品代碼QBS

諮詢委員會RA

決定相當於

器材摘要

Rayvolve is the device name listed in this FDA 510(k) record. The listed applicant is AZmed. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K260378. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rayvolve?

Rayvolve is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is AZmed. The 510(k) number is K260378.

When did Rayvolve receive FDA 510(k) clearance?

Rayvolve received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260378.

Who is the listed applicant for Rayvolve?

FDA 510(k) 記錄將 AZmed 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Rayvolve?

The FDA product code for Rayvolve is QBS.

其他以 AZmed 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。

K261378瑞維爾 AZchest K243831雷沃爾夫LN K243808Rayvolve PTX-PE 医療設備規範文本 Rayvolve PTX-PE 医療器材規範文本

相關器械（代碼：QBS）

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。

K261378瑞維爾 AZchestAZmed K242171TechCare 輕傷治療設備Milvue K240712icobrain 藝瑞Icometrix NV K240845瑞輝olveAzmed Sas K223491重症照護套件搭配氣胸偵測AI演算法，重症照護套件2.1，重症照護套件Ge Medical Systems, LLC K222176骨視圖Gleamer

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。