SonoHeart Hand-Carried Echocardiography System

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

510(k) Number

K994096 ↗

FDA Product Code

IYN

FDA applicant

Sonosite,Inc.

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sonosite Hand-Caried Untrasound System (Powerseries)

  Class II

  FDA 510(k) K021628 Active Cleared 31 May 2002

• Sonosite Hand-Carried Ultrasound System

  Class II

  FDA 510(k) K010374 Active Cleared 21 Feb 2001

• C1 Ultrasound System

  Class II

  FDA 510(k) K990806 Active Cleared 26 Mar 1999

• Titan High Resolution Ultrasound System and Sonosite Ultrasound System

  Class II

  FDA 510(k) K043452 Active Cleared 21 Dec 2004

• Lumenvu Catheter Guidance System

  Class II

  FDA 510(k) K093510 Active Cleared 23 Aug 2010

• Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System, Model L03073, L02245, L02464

  Class II

  FDA 510(k) K033367 Active Cleared 5 Nov 2003

See all devices from Sonosite, Inc. →

• Is the SonoHeart Hand-Carried Echocardiography System designed for single-use or can it be reused in clinical settings?

  The SonoHeart Hand-Carried Echocardiography System is explicitly described as a reusable medical device. This means it is intended for repeated use in clinical environments, such as emergency or critical care settings, where portability and durability are required for rapid cardiac imaging assessments. Reuse requires adherence to manufacturer-provided cleaning and maintenance protocols to ensure safety and performance.

• What types of clinical environments is the SonoHeart system intended for, and why is portability important?

  The SonoHeart is designed for diverse clinical settings, including emergency and critical care environments, where immediate cardiac evaluation is critical. Its portability allows for use at the patient’s bedside or even in pre-hospital settings, enabling rapid assessment of heart structure and function without requiring the patient to be moved to a fixed imaging location. This is particularly valuable in time-sensitive scenarios like trauma or acute cardiac events.

• How is the device regulated, and what does the FDA 510(k) clearance (K994096) indicate about its safety and equivalence?

  The SonoHeart Hand-Carried Echocardiography System holds FDA 510(k) clearance (K994096), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This classification under the Radiology advisory committee (RA) and as a Class II medical device indicates it has undergone regulatory review to ensure its safety and effectiveness for performing real-time cardiac imaging. The clearance does not imply it is MRI-safe, as explicitly noted in the device description.

• What are the key features that distinguish this system from traditional echocardiographic devices?

  The SonoHeart is distinguished by its hand-carried, portable design, making it ideal for use outside of fixed imaging labs. Unlike stationary systems, it enables bedside or pre-hospital cardiac imaging, which is critical in emergency or critical care scenarios where delays could impact patient outcomes. Its portability and real-time imaging capabilities are tailored for rapid assessment of heart structure and function, addressing the need for immediate diagnostic information in high-pressure environments.