FDA 510(k)

Extremity CT Imaging System

K-번호: K252249 · 2026-03-13

결정일2026-03-13

제품 코드JAK

자문 위원회RA

결정Substantially Equivalent

기기 요약

Extremity CT Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Mars Bioimaging , Ltd.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K252249. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Extremity CT Imaging System?

Extremity CT Imaging System is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Mars Bioimaging , Ltd.. The 510(k) number is K252249.

When did Extremity CT Imaging System receive FDA 510(k) clearance?

Extremity CT Imaging System received FDA 510(k) clearance on 2026-03-13, under 510(k) number K252249.

Who is the listed applicant for Extremity CT Imaging System?

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

What is the FDA product code for Extremity CT Imaging System?

The FDA product code for Extremity CT Imaging System is JAK.

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Extremity CT Imaging System

기기 요약

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관련 임상시험

관련 기기 (코드: JAK)

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