FDA 510(k)

Deep Capsule® (Deep Capsule US)

K-번호: K250655 · 2026-03-12

신청자Digestaid - Artificial Intelligence Development SA

결정일2026-03-12

제품 코드QZF

자문 위원회GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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)

기기 요약

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관련 임상시험

관련 기기 (코드: QZF)

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