FDA 510(k)

骨抑制ソフトウェア

K番号: K240281 · 2024-05-31

決定日2024-05-31

製品コードLLZ

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

Bone Suppression Software is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K240281. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Bone Suppression Software?

Bone Suppression Software is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K240281.

When did Bone Suppression Software receive FDA 510(k) clearance?

Bone Suppression Software received FDA 510(k) clearance on 2024-05-31, under 510(k) number K240281.

Who is the listed applicant for Bone Suppression Software?

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

What is the FDA product code for Bone Suppression Software?

The FDA product code for Bone Suppression Software is LLZ.

申請者としてKonica Minolta, Inc.を記載するその他の記録

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公式ソース

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