FDA 510(k)

Sonosite LX and Sonosite PX Ultrasound Systems

K-번호: K251106 · 2025-08-29

결정일2025-08-29

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Sonosite LX and Sonosite PX Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251106. 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 Sonosite LX and Sonosite PX Ultrasound Systems?

Sonosite LX and Sonosite PX Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K251106.

When did Sonosite LX and Sonosite PX Ultrasound Systems receive FDA 510(k) clearance?

Sonosite LX and Sonosite PX Ultrasound Systems received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251106.

Who is the listed applicant for Sonosite LX and Sonosite PX Ultrasound Systems?

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

What is the FDA product code for Sonosite LX and Sonosite PX Ultrasound Systems?

The FDA product code for Sonosite LX and Sonosite PX Ultrasound Systems is IYN.

FUJIFILM Sonosite, Inc.를 신청인으로 등재한 기타 기록

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

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관련 기기 (코드: IYN)

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