FDA 510(k)

第二次意見根尖放射透明度輪廓

K 號：K242600 · 2025-04-11

決定日期2025-04-11

產品代碼MYN

諮詢委員會RA

決定相當於

器材摘要

Second Opinion Periapical Radiolucency Contours is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242600. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Second Opinion Periapical Radiolucency Contours?

Second Opinion Periapical Radiolucency Contours is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Pearl, Inc.. The 510(k) number is K242600.

When did Second Opinion Periapical Radiolucency Contours receive FDA 510(k) clearance?

Second Opinion Periapical Radiolucency Contours received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242600.

Who is the listed applicant for Second Opinion Periapical Radiolucency Contours?

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 Periapical Radiolucency Contours?

The FDA product code for Second Opinion Periapical Radiolucency Contours is MYN.

其他以 Pearl, Inc. 為申請人之記錄

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相關器械（代碼：MYN）

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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