FDA 510(k)

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

K番号: K251268 · 2025-12-23

決定日2025-12-23

製品コードIYN

諮問委員会RA

決定Substantially Equivalent

医療機器の概要

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251268. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251268.

When did Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) receive FDA 510(k) clearance?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251268.

Who is the listed applicant for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

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

What is the FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

The FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is IYN.

申請者としてEdan Instruments, Inc.を記載するその他の記録

K251508Telemetry Monitor (iT30, iT50)K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)K251591Holter ECG and ABP system (HolterABP)K241882Fetal & Maternal Monitor (F15A, F15A Air)K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)K250214Acclarix AX8 シリーズ诊断超音波システム（モデル：Acclarix AX7、Acclarix AX8、Acclarix AX75、Acclarix AX78、Acclarix AX8 Exp、Acclarix AX8 Super）、Acclarix AX9 シリーズ诊断超音波システム（モデル：Acclarix AX9 Basic、Acclarix AX9、Acclarix AX9 Exp、Acclarix AX9 Super、Acclarix AX85、Acclarix AX88）

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関連機器（コード：IYN）

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