FDA 510(k)

ECHELON オーバル V6.2 MRI システム

K番号: K221619 · 2023-01-26

決定日2023-01-26

製品コードLNH

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

ECHELON Oval V6.2 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Healthcare Corporation. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K221619. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ECHELON Oval V6.2 MRI System?

ECHELON Oval V6.2 MRI System is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Fujifilm Healthcare Corporation. The 510(k) number is K221619.

When did ECHELON Oval V6.2 MRI System receive FDA 510(k) clearance?

ECHELON Oval V6.2 MRI System received FDA 510(k) clearance on 2023-01-26, under 510(k) number K221619.

Who is the listed applicant for ECHELON Oval V6.2 MRI System?

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

What is the FDA product code for ECHELON Oval V6.2 MRI System?

The FDA product code for ECHELON Oval V6.2 MRI System is LNH.

申請者としてFujifilm Healthcare Corporationを記載するその他の記録

K241429ECHELON Synergy MRIシステム K240571OASIS MRIシステム K223426ECHELON Synergy MRIシステム K213829SCENARIA ビューウィズ K220295ARIETTA50

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