FDA 510(k)

CMN 혈관 기능 및 virtually Expert for MRI, CT 및 CBCT

K-번호: K253831 · 2026-05-18

결정일2026-05-18

제품 코드LLZ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is the device name listed in this FDA 510(k) record. The listed applicant is Cercare Medical A/S. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K253831. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Cercare Medical A/S. The 510(k) number is K253831.

When did CMN Capillary Function with Virtual Expert for MRI, CT and CBCT receive FDA 510(k) clearance?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT received FDA 510(k) clearance on 2026-05-18, under 510(k) number K253831.

Who is the listed applicant for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

The FDA 510(k) record lists Cercare Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

The FDA product code for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is LLZ.

Cercare Medical A/S를 신청인으로 등재한 기타 기록

K260316CMN 혈관 기능 및 암학 virtually expert K241989세라케 메디칼 네우로스위트 (CMN) 혈관 기능과 virtually expert K230016세카레 메디칼 네우로스위트

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