FDA 510(k)

3Dicom MD

K-번호: K222470 · 2022-10-25

결정일2022-10-25

제품 코드LLZ

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

결정대체적으로 동일

기기 요약

3Dicom MD is the device name listed in this FDA 510(k) record. The listed applicant is Singular Health Pty, Ltd.. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K222470. 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 3Dicom MD?

3Dicom MD is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Singular Health Pty, Ltd.. The 510(k) number is K222470.

When did 3Dicom MD receive FDA 510(k) clearance?

3Dicom MD received FDA 510(k) clearance on 2022-10-25, under 510(k) number K222470.

Who is the listed applicant for 3Dicom MD?

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

What is the FDA product code for 3Dicom MD?

The FDA product code for 3Dicom MD is LLZ.

Singular Health Pty, Ltd.를 신청인으로 등재한 기타 기록

K2537843DICOM MD Cloud

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