FDA 510(k)

MiroCam® Capsule Endoscope System

K番号: K252617 · 2026-05-08

決定日2026-05-08

製品コードNEZ

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Substantially Equivalent

医療機器の概要

MiroCam® Capsule Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Intromedic Co., Ltd.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K252617. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the MiroCam® Capsule Endoscope System?

MiroCam® Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Intromedic Co., Ltd.. The 510(k) number is K252617.

When did MiroCam® Capsule Endoscope System receive FDA 510(k) clearance?

MiroCam® Capsule Endoscope System received FDA 510(k) clearance on 2026-05-08, under 510(k) number K252617.

Who is the listed applicant for MiroCam® Capsule Endoscope System?

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

What is the FDA product code for MiroCam® Capsule Endoscope System?

The FDA product code for MiroCam® Capsule Endoscope System is NEZ.

申請者としてIntromedic Co., Ltd.を記載するその他の記録

K180732MiroCam Capsule Endoscope System K170438MiroCam Capsule Endoscope System

公式ソース

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