FDA 510(k)

Deep Capsule® (Deep Capsule US)

K番号: K250655 · 2026-03-12

申請者Digestaid - Artificial Intelligence Development SA

決定日2026-03-12

製品コードQZF

諮問委員会GU

決定Substantially Equivalent

医療機器の概要

Deep Capsule® (Deep Capsule US) is the device name listed in this FDA 510(k) record. The listed applicant is Digestaid - Artificial Intelligence Development SA. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K250655. The device is classified under product code QZF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Deep Capsule® (Deep Capsule US)?

Deep Capsule® (Deep Capsule US) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Digestaid - Artificial Intelligence Development SA. The 510(k) number is K250655.

When did Deep Capsule® (Deep Capsule US) receive FDA 510(k) clearance?

Deep Capsule® (Deep Capsule US) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K250655.

Who is the listed applicant for Deep Capsule® (Deep Capsule US)?

The FDA 510(k) record lists Digestaid - Artificial Intelligence Development SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deep Capsule® (Deep Capsule US)?

The FDA product code for Deep Capsule® (Deep Capsule US) is QZF.

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Deep Capsule® (Deep Capsule US)

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：QZF）

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