FDA 510(k)

AspenView

K 號：K241425 · 2025-02-12

決定日期2025-02-12

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

AspenView is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Imaging Healthcare, Inc.. It received FDA 510(k) clearance on 2025-02-12 under 510(k) number K241425. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AspenView?

AspenView is a medical device that received FDA 510(k) clearance on 2025-02-12. The listed applicant is Aspen Imaging Healthcare, Inc.. The 510(k) number is K241425.

When did AspenView receive FDA 510(k) clearance?

AspenView received FDA 510(k) clearance on 2025-02-12, under 510(k) number K241425.

Who is the listed applicant for AspenView?

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

What is the FDA product code for AspenView?

The FDA product code for AspenView is LLZ.

其他以 Aspen Imaging Healthcare, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241346IODR1717 / IODR1417 / IODR1417-GF (數位平面X光檢測器)

相關器械（代碼：LLZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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