Color Flow Imaging

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

510(k) Number

K873096 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Scanhead 2.25MHZ Added to Ultramark 4

  Class II

  FDA 510(k) K843130 Active Cleared 6 Dec 1984

• Annular Array Scanhead

  Class II

  FDA 510(k) K871856 Active Cleared 28 Aug 1987

• Mark 500 Ultrasouond System

  Class II

  FDA 510(k) K820364 Active Cleared 26 Mar 1982

• TEEC Transducer

  Class II

  FDA 510(k) K883546 Active Cleared 7 Oct 1988

• Vitastat Ecg-1/Ecg-3 Electrocardiograph

  Class II

  FDA 510(k) K803309 Active Cleared 16 Jan 1981

• Access Scanheadss

  Class II

  FDA 510(k) K840953 Active Cleared 15 Jun 1984

See all devices from Advanced Technology Laboratories, Inc. →

• What clinical applications does Color Flow Imaging support in cardiovascular evaluations?

  Color Flow Imaging is designed to visualize blood flow within vessels and the heart, allowing clinicians to assess real-time flow direction, velocity, and turbulence. This modality is particularly useful for evaluating cardiovascular conditions by providing critical hemodynamic information, such as identifying blockages, valve dysfunction, or abnormal flow patterns in the heart and blood vessels.

• Is Color Flow Imaging supplied as a standalone device, or is it integrated into an existing system?

  Color Flow Imaging is supplied as part of an ultrasound system, meaning it is not a separate standalone device but rather a component integrated into the broader imaging platform. This integration allows clinicians to leverage the full capabilities of ultrasound technology while specifically utilizing the color Doppler features for flow assessment.

• How is Color Flow Imaging regulated, and what does its FDA clearance indicate?

  Color Flow Imaging holds an FDA 510(k) clearance (K873096) under the Traditional pathway, filed in 1987 and reviewed by the Radiology Advisory Committee. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the regulatory standards for safety and effectiveness as established by the FDA at the time of review.

• Where can Color Flow Imaging be used, and what types of clinical settings are appropriate for it?

  Color Flow Imaging is intended for use in clinical settings such as hospitals, diagnostic imaging centers, and cardiology clinics. Its design supports real-time hemodynamic assessments, making it suitable for environments where cardiovascular evaluations are performed, such as cardiac catheterization labs or outpatient imaging facilities.

• Does Color Flow Imaging come in different sizes or models, and if so, how might they differ?

  The provided data does not specify distinct sizes or models for Color Flow Imaging beyond its classification as part of an ultrasound system. However, since it is integrated into an ultrasound platform, variations in models may exist based on the broader system’s capabilities, such as different probe types or imaging resolutions. For precise details on available models, consulting the manufacturer’s documentation or support team would be necessary.