FDA 510(k)

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

K 號：K183606 · 2019-04-08

決定日期2019-04-08

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2019-04-08 under 510(k) number K183606. 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 Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is a medical device that received FDA 510(k) clearance on 2019-04-08. The listed applicant is Scandidos AB. The 510(k) number is K183606.

When did Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) receive FDA 510(k) clearance?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) received FDA 510(k) clearance on 2019-04-08, under 510(k) number K183606.

Who is the listed applicant for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

The FDA 510(k) record lists Scandidos AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

The FDA product code for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is IYE.

其他以 Scandidos AB 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。

K223234Delta4洞察 K151426ScandiDos Delta4 Discover，另名：ScandiDos Delta4 Discover+

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。

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官方來源

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