Rotograph Prime（商標為Villa Sistemi Medicali），I-MAX（商標為Owandy Radiology）
K 號：K162190 · 2017-07-06
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器材摘要
常見問題
What is the Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)?
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K162190.
When did Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) receive FDA 510(k) clearance?
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) received FDA 510(k) clearance on 2017-07-06, under 510(k) number K162190.
Who is the listed applicant for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)?
The FDA 510(k) record lists Villa Sistemi Medicali S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)?
The FDA product code for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) is MUH.
相關臨床試驗
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其他以 Villa Sistemi Medicali S.P.A. 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：MUH）
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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