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FDA 510(k)

VistaPano S Ceph 2.0 (VistaPano S Ceph)；VistaPano S 2.0 (VistaPano S)；ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph)；ProVecta S-Pan 2.0 (ProVecta S-Pan)

K 號：K240040 · 2024-10-25

申請人VATECH Co., Ltd.
決定日期2024-10-25
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K240040. 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 VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)?

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K240040.

When did VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) receive FDA 510(k) clearance?

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) received FDA 510(k) clearance on 2024-10-25, under 510(k) number K240040.

Who is the listed applicant for VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)?

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

What is the FDA product code for VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)?

The FDA product code for VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) is MUH.

相關臨床試驗

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其他以 VATECH Co., Ltd. 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。

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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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