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FDA 510(k)

IntelliSpace 放射學

K 號:K182926 · 2018-12-06

決定日期2018-12-06
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

IntelliSpace Radiology is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare Informatics, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K182926. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IntelliSpace Radiology?

IntelliSpace Radiology is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Philips Healthcare Informatics, Inc.. The 510(k) number is K182926.

When did IntelliSpace Radiology receive FDA 510(k) clearance?

IntelliSpace Radiology received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182926.

Who is the listed applicant for IntelliSpace Radiology?

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

What is the FDA product code for IntelliSpace Radiology?

The FDA product code for IntelliSpace Radiology is LLZ.

相關臨床試驗

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相關器械(代碼:LLZ)

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

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