FDA 510(k)

MICSI-RMT

K 號：K241121 · 2024-07-17

決定日期2024-07-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

MICSI-RMT is the device name listed in this FDA 510(k) record. The listed applicant is Microstructure Imaging, Inc.. It received FDA 510(k) clearance on 2024-07-17 under 510(k) number K241121. 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 MICSI-RMT?

MICSI-RMT is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Microstructure Imaging, Inc.. The 510(k) number is K241121.

When did MICSI-RMT receive FDA 510(k) clearance?

MICSI-RMT received FDA 510(k) clearance on 2024-07-17, under 510(k) number K241121.

Who is the listed applicant for MICSI-RMT?

FDA 510(k) 記錄將 Microstructure Imaging, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for MICSI-RMT?

The FDA product code for MICSI-RMT is LLZ.

其他以 Microstructure Imaging, 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。

K261305MICSI-PET

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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