FDA 510(k)

RemedyLogic AI 腰椎脊椎 MRI 閱讀器

K 號：K241108 · 2024-10-30

決定日期2024-10-30

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

RemedyLogic AI MRI Lumbar Spine Reader is the device name listed in this FDA 510(k) record. The listed applicant is Remedy Logic, Inc.. It received FDA 510(k) clearance on 2024-10-30 under 510(k) number K241108. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RemedyLogic AI MRI Lumbar Spine Reader?

RemedyLogic AI MRI Lumbar Spine Reader is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is Remedy Logic, Inc.. The 510(k) number is K241108.

When did RemedyLogic AI MRI Lumbar Spine Reader receive FDA 510(k) clearance?

RemedyLogic AI MRI Lumbar Spine Reader received FDA 510(k) clearance on 2024-10-30, under 510(k) number K241108.

Who is the listed applicant for RemedyLogic AI MRI Lumbar Spine Reader?

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

What is the FDA product code for RemedyLogic AI MRI Lumbar Spine Reader?

The FDA product code for RemedyLogic AI MRI Lumbar Spine Reader is QIH.

相關器械（代碼：QIH）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：QIH）

官方來源