Cardiac Scanner and Processing System

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

510(k) Number

K110507 ↗

FDA Product Code

KPS

FDA applicant

Spectrum Dynamics (Israel) , Ltd.

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• What is the primary purpose of the Cardiac Scanner and Processing System, and where is it typically used?

  The Cardiac Scanner and Processing System is designed to detect gamma-ray radionuclides within the body to generate cross-sectional images through digital reconstruction. This enables precise visualization of radiotracer distribution, primarily for diagnostic purposes in radiology settings. It is specifically intended for use in environments where cardiac imaging and radiotracer analysis are performed, such as hospitals or specialized diagnostic centers.

• Is the Cardiac Scanner and Processing System intended for single-use or reusable applications, and what maintenance is required?

  The Cardiac Scanner and Processing System is supplied as a reusable medical device. Since it is reusable, it requires proper calibration, regular maintenance, and adherence to radiation safety protocols to ensure accurate imaging and patient safety. Facility staff must follow manufacturer guidelines and regulatory compliance to maintain optimal performance.

• How is the regulatory status of this device determined, and what classification does it hold?

  The Cardiac Scanner and Processing System holds FDA 510(k) clearance under the classification of a Class II device. This classification is based on its intended use for detecting gamma-ray radionuclides and generating diagnostic images, which falls under the regulatory framework for radiology devices. The clearance type is traditional, and it was determined to be substantially equivalent to a predicate device.

• What storage and handling requirements should be followed for this device?

  The Cardiac Scanner and Processing System must be stored and handled in compliance with regulatory guidelines to ensure accurate imaging and patient safety. While the data does not specify exact storage conditions, it emphasizes adherence to radiation safety protocols and proper maintenance procedures. Facilities should follow manufacturer instructions and regulatory standards to maintain device integrity and functionality.

• Does this device require any specific radiation safety protocols, and why?

  Yes, the Cardiac Scanner and Processing System requires adherence to radiation safety protocols because it operates by detecting gamma-ray radionuclides. Since radiation exposure poses risks, proper handling, calibration, and maintenance are critical to minimize patient and operator exposure while ensuring diagnostic accuracy. These protocols are essential for compliance with regulatory requirements and safe operation.