FDA 510(k)

True 3D Viewer

K-번호: K201365 · 2020-07-17

결정일2020-07-17

제품 코드LLZ

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

결정Substantially Equivalent

기기 요약

True 3D Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Echopixel, Inc.. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201365. 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 True 3D Viewer?

True 3D Viewer is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Echopixel, Inc.. The 510(k) number is K201365.

When did True 3D Viewer receive FDA 510(k) clearance?

True 3D Viewer received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201365.

Who is the listed applicant for True 3D Viewer?

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

What is the FDA product code for True 3D Viewer?

The FDA product code for True 3D Viewer is LLZ.

Echopixel, Inc.를 신청인으로 등재한 기타 기록

K193149True 3D Viewer Software K170167True 3D Viewer Software

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