Interspec Apogee Echocardiograph

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Interspec Apogee

510(k) Number

K903839 ↗

FDA Product Code

DXK

Device Class

Class II

Regulation

21 CFR Part 870.2330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioscan with Doppler Option

  Class II

  FDA 510(k) K862913 Active Cleared 4 Nov 1986

• Ultrasound Imagaing System and Doppler Flowmeter

  Class II

  FDA 510(k) K920678 Active Cleared 2 Apr 1992

• Ultrasonic Imaging System (Modified)

  Class II

  FDA 510(k) K860568 Active Cleared 11 Aug 1986

• Cardioscan Doppler Option

  Class II

  FDA 510(k) K860579 Active Cleared 30 Jun 1986

• Interspec Apogee, Modification

  Class II

  FDA 510(k) K910049 Active Cleared 29 Apr 1991

• Interspec Apogee Cla

  Class II

  FDA 510(k) K924231 Active Cleared 14 Jun 1993

See all devices from Interspec, Inc. →

• What is the Interspec Apogee used for?

  The Interspec Apogee is an echocardiograph designed specifically for cardiovascular imaging. It uses high-frequency sound waves to generate real-time images of the heart’s structures and function, allowing clinicians to assess cardiac anatomy, motion, and blood flow. The integrated Doppler capability further enables measurement of blood flow velocities and volumetric flow rates within the heart and major vessels, making it essential for diagnosing and evaluating cardiac conditions.

• How is the Interspec Apogee supplied?

  The Interspec Apogee is supplied as a standalone ultrasound imaging system with integrated Doppler functionality. It is intended for use in radiology and cardiovascular diagnostic settings, providing a complete solution for cardiac evaluations without requiring additional peripheral equipment.

• Is the Interspec Apogee intended for single-use or reusable applications?

  The Interspec Apogee is cleared for both single-use and reusable applications, though specific sterility requirements are not detailed in the regulatory data. Users must follow established infection control protocols to ensure safe reuse if applicable, particularly in clinical environments where multiple patients are evaluated.

• Does the Interspec Apogee have size variations or model-specific differences?

  No specific size variations are noted for the Interspec Apogee beyond the model designation itself. The device is identified by its model name, and no additional variants or configurations are referenced in the available regulatory documentation.

• What regulatory pathway does the Interspec Apogee follow?

  The Interspec Apogee echocardiograph is authorized under the FDA 510(k) clearance pathway, specifically with clearance number K903839. It is classified as a Class II device and is substantially equivalent to predicate devices under the regulatory framework outlined in 870.2330 for cardiovascular diagnostic imaging.