Cardiospect D90/Cardio Cam

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

510(k) Number

K021823 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Neurospectquad Gamma Camera

  Class II

  FDA 510(k) K013353 Active Cleared 4 Mar 2002

• What clinical applications is the CardioSPECT D90/CARDIO CAM primarily used for in nuclear cardiology imaging?

  The CardioSPECT D90/CARDIO CAM is designed specifically for single-photon emission computed tomography (SPECT) imaging to visualize myocardial perfusion. This enables clinicians to assess coronary artery disease and evaluate cardiac function by tracking radiotracer distribution within the heart tissue. It is not intended for general radiology imaging but is specialized for nuclear cardiology evaluations.

• Is the CardioSPECT D90/CARDIO CAM a single-use or reusable device, and what maintenance is required?

  The CardioSPECT D90/CARDIO CAM is a reusable system, meaning it is not intended for single-use. Proper calibration and maintenance are required to ensure accurate imaging performance, as outlined in the manufacturer’s guidelines. This includes regular servicing to maintain the device’s functionality for nuclear cardiology imaging.

• What regulatory pathway was followed for FDA clearance of the CardioSPECT D90/CARDIO CAM, and what does this mean for its use?

  The CardioSPECT D90/CARDIO CAM received FDA clearance through a 510(k) submission, classified as a Class II medical device under regulation number 892.1200. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for nuclear cardiology imaging. The clearance indicates it is legally marketable in the U.S. for its intended use.

• Are there multiple models or configurations of the CardioSPECT D90/CARDIO CAM, and how can I identify the correct registration number for my facility?

  The CardioSPECT D90/CARDIO CAM appears to be available in multiple configurations, as evidenced by the extensive list of FEI numbers (e.g., 3015232217, 3002808139, etc.) and registration numbers provided in the regulatory data. These identifiers correspond to different models or variants of the system. To confirm the correct registration number for your facility, check the device’s serial number or consult the manufacturer’s documentation or records, as these numbers are tied to specific units.

• Does the CardioSPECT D90/CARDIO CAM require any special handling or storage conditions?

  The regulatory data does not specify sterility requirements or MRI safety information for the CardioSPECT D90/CARDIO CAM, but since it is a reusable medical device used in radiology settings, it should be stored in a clean, controlled environment to prevent contamination or damage. Follow the manufacturer’s instructions for proper maintenance, calibration, and storage to ensure optimal performance and longevity of the system.