FDA 510(k)

Insight Enhanced™ DRF (EN-1002-01)

K 號：K251650 · 2025-09-16

決定日期2025-09-16

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

Insight Enhanced™ DRF (EN-1002-01) is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Engineering, LLC. It received FDA 510(k) clearance on 2025-09-16 under 510(k) number K251650. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Insight Enhanced™ DRF (EN-1002-01)?

Insight Enhanced™ DRF (EN-1002-01) is a medical device that received FDA 510(k) clearance on 2025-09-16. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K251650.

When did Insight Enhanced™ DRF (EN-1002-01) receive FDA 510(k) clearance?

Insight Enhanced™ DRF (EN-1002-01) received FDA 510(k) clearance on 2025-09-16, under 510(k) number K251650.

Who is the listed applicant for Insight Enhanced™ DRF (EN-1002-01)?

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

What is the FDA product code for Insight Enhanced™ DRF (EN-1002-01)?

The FDA product code for Insight Enhanced™ DRF (EN-1002-01) is JAA.

其他以 Imaging Engineering, LLC 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。

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相關器械（代碼：JAA）

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。

K253103Nexus DRF數位X光影像系統Varex Imaging Corporation K242488Soteria E-ViewOmega Medical Imaging, LLC K242948Adora DRFi (04550010)Nrt X-Ray A/S K233380TRIDENT 電子顯微鏡系統Dornier Medtech America K233945ProxiDiagnost N90 / 精準CRF (706110, 706400)Philips Medical Systems Dmc GmbH K232910CombiDiagnost R90Philips Medical Systems Dmc GmbH

官方來源

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