FDA 510(k)

TRIOS Dx (R1)

K 號：K260082 · 2026-04-10

決定日期2026-04-10

產品代碼SHQ

諮詢委員會DE

決定相當於

器材摘要

TRIOS Dx (R1) is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape TRIOS A/S. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260082. The device is classified under product code SHQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRIOS Dx (R1)?

TRIOS Dx (R1) is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is 3Shape TRIOS A/S. The 510(k) number is K260082.

When did TRIOS Dx (R1) receive FDA 510(k) clearance?

TRIOS Dx (R1) received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260082.

Who is the listed applicant for TRIOS Dx (R1)?

The FDA 510(k) record lists 3Shape TRIOS A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOS Dx (R1)?

The FDA product code for TRIOS Dx (R1) is SHQ.

其他以 3Shape TRIOS A/S 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。

K242103TRIOS準備針 K221249L1P-1F (TRIOS 5)

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

其他以 3Shape TRIOS A/S 為申請人之記錄

官方來源