Siemens Si-400

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914013 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K904017 Active Cleared 21 Mar 1991

• Sonoline Cf

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  FDA 510(k) K891449 Active Cleared 5 Oct 1989

• Siemens Transesophageal Echo Tee Transducer

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  FDA 510(k) K891238 Active Cleared 5 Jun 1989

• Si-1200 / Ilus

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  FDA 510(k) K911200 Active Cleared 17 Jun 1991

• Si-450/Ilus (Intraluminal Ultrasound)

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  FDA 510(k) K912361 Active Cleared 2 Dec 1991

• 5 Mhz Adult/Pedi Transesophageal Echo(Tee) Transdu

  Class II

  FDA 510(k) K910669 Active Cleared 15 Mar 1991

See all devices from Siemens Ultrasound, Inc. →

• What is the Siemens SI-400 used for in medical imaging?

  The Siemens SI-400 is a Class II ultrasound imaging system designed for diagnostic radiology. It generates real-time visual images of internal body structures using high-frequency sound waves, allowing clinicians to assess organ size, shape, and positioning. This device supports evaluations in obstetrics, cardiology, and abdominal imaging, enabling non-invasive diagnostic procedures across these specialties.

• Is the Siemens SI-400 a single-use or reusable device?

  The Siemens SI-400 is supplied as a reusable medical device. It is intended for use in radiology departments and clinical settings, requiring proper maintenance and calibration to ensure accurate imaging performance over time. Reusability is typical for high-end diagnostic equipment like this ultrasound system.

• What regulatory clearance does the Siemens SI-400 hold?

  The Siemens SI-400 was cleared for market distribution in the United States under FDA 510(k) clearance (K914013) in 1991. It is classified under product code IYO and was determined to be substantially equivalent to a legally marketed predicate device by the FDA’s Radiology Advisory Committee.

• Does the SI-400 require any special storage conditions?

  While the regulatory data does not specify sterility or single-use requirements, the Siemens SI-400 is a reusable device intended for clinical use. Proper storage should include protection from physical damage, dust, and environmental contaminants. Regular maintenance and calibration are essential to preserve imaging accuracy and functionality, as outlined in the device’s operational guidelines.

• What types of medical evaluations can the SI-400 support?

  The SI-400 supports a broad range of diagnostic evaluations, including obstetrics (e.g., fetal imaging), cardiology (e.g., heart structure assessment), and abdominal imaging (e.g., liver, kidney, or gallbladder evaluation). Its real-time imaging capability allows clinicians to visualize internal structures dynamically, aiding in accurate diagnosis and monitoring of various conditions.