FDA 510(k)

QUIBIM精準前列腺 (qp-Prostate)

K 號：K203582 · 2021-02-04

決定日期2021-02-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

QUIBIM Precision Prostate (qp-Prostate) is the device name listed in this FDA 510(k) record. The listed applicant is Quibim S.L.. It received FDA 510(k) clearance on 2021-02-04 under 510(k) number K203582. 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 QUIBIM Precision Prostate (qp-Prostate)?

QUIBIM Precision Prostate (qp-Prostate) is a medical device that received FDA 510(k) clearance on 2021-02-04. The listed applicant is Quibim S.L.. The 510(k) number is K203582.

When did QUIBIM Precision Prostate (qp-Prostate) receive FDA 510(k) clearance?

QUIBIM Precision Prostate (qp-Prostate) received FDA 510(k) clearance on 2021-02-04, under 510(k) number K203582.

Who is the listed applicant for QUIBIM Precision Prostate (qp-Prostate)?

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

What is the FDA product code for QUIBIM Precision Prostate (qp-Prostate)?

The FDA product code for QUIBIM Precision Prostate (qp-Prostate) is LLZ.

其他以 Quibim S.L. 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。

K242683QP-Prostate® CAD K232231QP-Brain®

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。

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官方來源

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