FDA 510(k)

MERGE 유니버설 뷰어 (MUV)

K-번호: K250301 · 2025-04-14

결정일2025-04-14

제품 코드LLZ

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

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기기 요약

Merge Universal Viewer (MUV) is the device name listed in this FDA 510(k) record. The listed applicant is Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2025-04-14 under 510(k) number K250301. 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 Merge Universal Viewer (MUV)?

Merge Universal Viewer (MUV) is a medical device that received FDA 510(k) clearance on 2025-04-14. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K250301.

When did Merge Universal Viewer (MUV) receive FDA 510(k) clearance?

Merge Universal Viewer (MUV) received FDA 510(k) clearance on 2025-04-14, under 510(k) number K250301.

Who is the listed applicant for Merge Universal Viewer (MUV)?

The FDA 510(k) record lists Merge Healthcare Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merge Universal Viewer (MUV)?

The FDA product code for Merge Universal Viewer (MUV) is LLZ.

Merge Healthcare Incorporated를 신청인으로 등재한 기타 기록

K233326헤모, 모델 RCSV2 K203104IBM iConnect 액세스 K192455PACS 통합 K192276카드리오 K182290IBM iConnect 액세스 K173475PACS 통합

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