FDA 510(k)

ソノサイト LXおよびソノサイト PX 超音波システム

K番号: K251106 · 2025-08-29

決定日2025-08-29

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてFUJIFILM Sonosite, Inc.を記載するその他の記録

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