FDA 510(k)

Yushan X-Ray Flat Panel Detector

K番号: K250211 · 2025-07-22

決定日2025-07-22

製品コードMQB

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

Yushan X-Ray Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K250211. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Yushan X-Ray Flat Panel Detector?

Yushan X-Ray Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Innocare Optoelectronics Corp.. The 510(k) number is K250211.

When did Yushan X-Ray Flat Panel Detector receive FDA 510(k) clearance?

Yushan X-Ray Flat Panel Detector received FDA 510(k) clearance on 2025-07-22, under 510(k) number K250211.

Who is the listed applicant for Yushan X-Ray Flat Panel Detector?

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

What is the FDA product code for Yushan X-Ray Flat Panel Detector?

The FDA product code for Yushan X-Ray Flat Panel Detector is MQB.

申請者としてInnocare Optoelectronics Corp.を記載するその他の記録

K243171Yushan X-Ray Flat Panel Detector K220510Yushan X-Ray Flat Panel Detector with DROC K210988Yushan X-Ray Flat Panel Detector with DROC K201528Yushan X-Ray Flat Panel Detector with DROC K191939Yushan X-Ray Flat Panel Detector

公式ソース

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