FDA 510(k)

第二意見® 3D

K 號：K243989 · 2025-05-23

決定日期2025-05-23

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Second Opinion® 3D is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K243989. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Second Opinion® 3D?

Second Opinion® 3D is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Pearl, Inc.. The 510(k) number is K243989.

When did Second Opinion® 3D receive FDA 510(k) clearance?

Second Opinion® 3D received FDA 510(k) clearance on 2025-05-23, under 510(k) number K243989.

Who is the listed applicant for Second Opinion® 3D?

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

What is the FDA product code for Second Opinion® 3D?

The FDA product code for Second Opinion® 3D is QIH.

其他以 Pearl, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

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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