Kontron Sigma ISC Echocardiograph System

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K852543 ↗

FDA Product Code

DXK

Device Class

Class II

Regulation

21 CFR Part 870.2330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Kontron Instruments, Inc. →

• What is the primary use of the Kontron Sigma ISC Echocardiograph System in clinical settings?

  The Kontron Sigma ISC Echocardiograph System is designed specifically for cardiovascular imaging, producing ultrasonic images of the heart to aid in diagnostic evaluations. This allows clinicians to assess heart structure and function, which is essential for diagnosing and monitoring cardiovascular conditions.

• How was the regulatory approval for this device obtained, and what does that mean for its use?

  The device was cleared through the FDA’s 510(k) process under submission K852543, with a decision date of September 20, 1985. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the U.S. for its intended cardiovascular diagnostic use.

• Is this device intended for single-use or repeated use in a clinical environment?

  The provided data does not specify whether the Kontron Sigma ISC Echocardiograph System is single-use or reusable. However, as an imaging system, echocardiographs are typically designed for repeated use in clinical settings, requiring proper cleaning, maintenance, and sterilization protocols between patients to ensure safety and functionality.

• What regulatory classification and product code does this device hold, and how does that affect its oversight?

  The Kontron Sigma ISC Echocardiograph System is classified as a Class II medical device under FDA regulation number 870.2330 and product code DXK. This classification indicates it is subject to special controls, including performance standards and post-market surveillance, to ensure its safety and effectiveness in cardiovascular diagnostic imaging.

• What type of advisory committee was involved in the review process for this device?

  The review of the Kontron Sigma ISC Echocardiograph System was conducted under the Cardiovascular (CV) advisory committee, which provides expert input on the safety and effectiveness of cardiovascular-related medical devices during the FDA’s 510(k) review process.