FDA 510(k)

Lumify Diagnostic Ultrasound System

K-번호: K242519 · 2025-05-15

결정일2025-05-15

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Lumify Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K242519. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Lumify Diagnostic Ultrasound System?

Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Philips Ultrasound. The 510(k) number is K242519.

When did Lumify Diagnostic Ultrasound System receive FDA 510(k) clearance?

Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2025-05-15, under 510(k) number K242519.

Who is the listed applicant for Lumify Diagnostic Ultrasound System?

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

What is the FDA product code for Lumify Diagnostic Ultrasound System?

The FDA product code for Lumify Diagnostic Ultrasound System is IYN.

Philips Ultrasound를 신청인으로 등재한 기타 기록

K242670Lumify Diagnostic Ultrasound System K232500Lumify Diagnostic Ultrasound System K223771Lumify Diagnostic Ultrasound System

관련 기기 (코드: IYN)

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