醫用放射線劑量測量系統 microSTARii
K 號：K192196 · 2019-12-27
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器材摘要
Medical Radiation Dosimetry System microSTARii is the device name listed in this FDA 510(k) record. The listed applicant is Landauer. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192196. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Medical Radiation Dosimetry System microSTARii?
Medical Radiation Dosimetry System microSTARii is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Landauer. The 510(k) number is K192196.
When did Medical Radiation Dosimetry System microSTARii receive FDA 510(k) clearance?
Medical Radiation Dosimetry System microSTARii received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192196.
Who is the listed applicant for Medical Radiation Dosimetry System microSTARii?
The FDA 510(k) record lists Landauer as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Radiation Dosimetry System microSTARii?
The FDA product code for Medical Radiation Dosimetry System microSTARii is IYE.
相關臨床試驗
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相關器械（代碼：IYE）
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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