FDA 510(k)

MAGENTIQ-COLO (ME-APDS)

K番号: K260724 · 2026-04-03

決定日2026-04-03

製品コードQNP

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

MAGENTIQ-COLO (ME-APDS) is the device name listed in this FDA 510(k) record. The listed applicant is Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K260724. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the MAGENTIQ-COLO (ME-APDS)?

MAGENTIQ-COLO (ME-APDS) is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Magentiq Eye, Ltd.. The 510(k) number is K260724.

When did MAGENTIQ-COLO (ME-APDS) receive FDA 510(k) clearance?

MAGENTIQ-COLO (ME-APDS) received FDA 510(k) clearance on 2026-04-03, under 510(k) number K260724.

Who is the listed applicant for MAGENTIQ-COLO (ME-APDS)?

The FDA 510(k) record lists Magentiq Eye, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGENTIQ-COLO (ME-APDS)?

The FDA product code for MAGENTIQ-COLO (ME-APDS) is QNP.

申請者としてMagentiq Eye, Ltd.を記載するその他の記録

K252178MAGENTIQ-COLO (ME-APDS)K244023MAGENTIQ-COLO (ME-APDS)K223473ME-APDS™；マグネティーク-コーロ™

公式ソース

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