FDA 510(k)

iQFlex M モバイル X線システム、iQFlex MD モバイル X線システム

K番号: K221081 · 2022-06-13

決定日2022-06-13

製品コードIZL

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

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is First Source, Inc.. It received FDA 510(k) clearance on 2022-06-13 under 510(k) number K221081. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System?

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2022-06-13. The listed applicant is First Source, Inc.. The 510(k) number is K221081.

When did iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System receive FDA 510(k) clearance?

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System received FDA 510(k) clearance on 2022-06-13, under 510(k) number K221081.

Who is the listed applicant for iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System?

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

What is the FDA product code for iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System?

The FDA product code for iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is IZL.

申請者としてFirst Source, Inc.を記載するその他の記録

K240009iQFlex プロ K203703I-Q ビューウェア

公式ソース

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