FDA 510(k)

Axial3D 클라우드 세그먼션 서비스

K-번호: K221511 · 2022-06-23

결정일2022-06-23

제품 코드LLZ

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

결정대체적으로 동일

기기 요약

Axial3D Cloud Segmentation Service is the device name listed in this FDA 510(k) record. The listed applicant is Axial Medical Printing Limited. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K221511. 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 Axial3D Cloud Segmentation Service?

Axial3D Cloud Segmentation Service is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Axial Medical Printing Limited. The 510(k) number is K221511.

When did Axial3D Cloud Segmentation Service receive FDA 510(k) clearance?

Axial3D Cloud Segmentation Service received FDA 510(k) clearance on 2022-06-23, under 510(k) number K221511.

Who is the listed applicant for Axial3D Cloud Segmentation Service?

The FDA 510(k) record lists Axial Medical Printing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axial3D Cloud Segmentation Service?

The FDA product code for Axial3D Cloud Segmentation Service is LLZ.

Axial Medical Printing Limited를 신청인으로 등재한 기타 기록

K250369Axial3D 인사이트 K231607Axial3D 클라우드 세그먼션 서비스 K232841Axial3D 인사이트 K222745Axial3D 인사이트

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