雷射站 12A
K 號：K222312 · 2023-03-29
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器材摘要
RayStation 12A is the device name listed in this FDA 510(k) record. The listed applicant is RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K222312. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RayStation 12A?
RayStation 12A is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is RaySearch Laboratories AB (PUBL). The 510(k) number is K222312.
When did RayStation 12A receive FDA 510(k) clearance?
RayStation 12A received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222312.
Who is the listed applicant for RayStation 12A?
The FDA 510(k) record lists RaySearch Laboratories AB (PUBL) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RayStation 12A?
The FDA product code for RayStation 12A is MUJ.
相關臨床試驗
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其他以 RaySearch Laboratories AB (PUBL) 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。
相關器械（代碼：MUJ）
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。
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。
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