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FDA 510(k)

DEXIS Ti2 隻內口腔感應器，DEXIS IXS 尺寸 1 隻內口腔感應器，DEXIS IXS 尺寸 2 隻內口腔感應器

K 號：K233053 · 2023-11-21

申請人Dental Imaging Technologies Corporation
決定日期2023-11-21
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Dental Imaging Technologies Corporation. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K233053. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor?

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Dental Imaging Technologies Corporation. The 510(k) number is K233053.

When did DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor receive FDA 510(k) clearance?

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233053.

Who is the listed applicant for DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor?

The FDA 510(k) record lists Dental Imaging Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor?

The FDA product code for DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor is MUH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Dental Imaging Technologies Corporation 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。

K253864NOMAD Pro 3

相關器械（代碼：MUH）

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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