TCS-Medcon Telecardiology System

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

Full name

The Tcs-Medcon's Telecardiology System

510(k) Number

K974679 ↗

FDA Product Code

IZI

FDA applicant

Medcon , Ltd.

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the TCS-Medcon Telecardiology System used for?

  The TCS-Medcon Telecardiology System is designed for storing, displaying, analyzing, communicating, and recording cardiac data. It enables real-time transmission and review of electrocardiographic (ECG) and angiographic imaging, making it ideal for remote telecardiology services in radiology departments and cardiac care environments. This facilitates diagnostic and monitoring workflows by allowing clinicians to assess cardiac data efficiently.

• How is the TCS-Medcon Telecardiology System supplied and is it single-use?

  The system is supplied as a reusable medical device, meaning it is intended for repeated use across multiple patients. Unlike single-use devices, it is engineered to maintain functionality and reliability over time with proper maintenance and cleaning protocols. This design ensures cost-effectiveness and sustainability in clinical settings.

• Does the TCS-Medcon Telecardiology System meet MRI safety guidelines?

  The device operates within standard MRI safety guidelines for non-MRI environments. While it is not classified as MRI-compatible, it is designed to function safely in radiology departments where MRI procedures are conducted, provided it is used in areas not directly involved in MRI scanning. Always follow facility-specific safety protocols to ensure proper usage.

• What regulatory clearance does the TCS-Medcon Telecardiology System hold?

  The TCS-Medcon Telecardiology System holds FDA 510(k) clearance under the classification of Class 2, with the product code IZI and regulation number 892.1600. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards for radiology use.

• How should the TCS-Medcon Telecardiology System be stored and handled?

  Storage and handling of the TCS-Medcon Telecardiology System follow standard medical device protocols to maintain functionality and ensure sterility where applicable. Since it is reusable, it should be cleaned and disinfected according to manufacturer guidelines after each use. Proper storage conditions—such as protecting it from physical damage, extreme temperatures, and contamination—are critical to preserving its performance and longevity in clinical settings.