FDA 510(k)

CORIOGRAPH 事前計画およびモデリングサービス

K番号: K250921 · 2025-06-25

決定日2025-06-25

製品コードPBF

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定Substantially Equivalent

医療機器の概要

CORIOGRAPH Pre-Op Planning and Modeling Services is the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K250921. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CORIOGRAPH Pre-Op Planning and Modeling Services?

CORIOGRAPH Pre-Op Planning and Modeling Services is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K250921.

When did CORIOGRAPH Pre-Op Planning and Modeling Services receive FDA 510(k) clearance?

CORIOGRAPH Pre-Op Planning and Modeling Services received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250921.

Who is the listed applicant for CORIOGRAPH Pre-Op Planning and Modeling Services?

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

What is the FDA product code for CORIOGRAPH Pre-Op Planning and Modeling Services?

The FDA product code for CORIOGRAPH Pre-Op Planning and Modeling Services is PBF.

申請者としてBlue Belt Technologies, Inc.を記載するその他の記録

K260601REAL INTELLIGENCE™ CORI™K252841リアルインテリジェンス™ コリ™ エクストラ（コリエクストラ）K242272CORIOGRAPH 事前計画およびモデリングサービス K240139リアルインテリジェンス™ コリ™K231963REAL INTELLIGENCE™ CORI™K221224リアルインテリジェンスコリ

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