FDA 510(k)

VistaSoft 4.0 及 VisionX 4.0

K 號：K250947 · 2025-08-27

決定日期2025-08-27

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

VistaSoft 4.0 and VisionX 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K250947. 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 VistaSoft 4.0 and VisionX 4.0?

VistaSoft 4.0 and VisionX 4.0 is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Durr Dental SE. The 510(k) number is K250947.

When did VistaSoft 4.0 and VisionX 4.0 receive FDA 510(k) clearance?

VistaSoft 4.0 and VisionX 4.0 received FDA 510(k) clearance on 2025-08-27, under 510(k) number K250947.

Who is the listed applicant for VistaSoft 4.0 and VisionX 4.0?

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

What is the FDA product code for VistaSoft 4.0 and VisionX 4.0?

The FDA product code for VistaSoft 4.0 and VisionX 4.0 is QIH.

其他以 Durr Dental SE 為申請人之記錄

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