CardioCam Model 9CSY0799
by Danish Diagnostic Development A/S Denmark 510(k)
510(k) K011611
Product code KPS
Overview
The CardioCam Model 9CSY0799 is a dual-head diagnostic imaging system classified as a System, Tomography, Computed, Emission. It acquires data for multi-slice cardiac imaging by detecting radioactivity distribution within the body when paired with radiopharmaceuticals such as Tc-99m, Tl-201, or Co-57. The device generates high-resolution 3D images, including static, gated, and dynamic representations of biochemical and metabolic processes in cardiac tissue.
This system is intended for use in radiology settings by trained medical professionals. It is a reusable device, not subject to single-use constraints, and operates under FDA 510(k) clearance (K011611) as a Class II medical device. The CardioCam Model 9CSY0799 was authorized in 2001 and adheres to regulatory standards outlined in 21 CFR 892.1200. No specific MRI safety classification or sterility requirements are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011611 | Date8 Jun 2001 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1079-04
Software problems may cause the detector head to drift unexpectedly
Specification
- 510(k) Number
- FDA Product Code
- KPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Danish Diagnostic Development A/S
Questions
What types of radiopharmaceuticals is the CardioCam Model 9CSY0799 designed to work with for cardiac imaging?
The CardioCam Model 9CSY0799 is specifically designed to detect radioactivity distribution for cardiac imaging when paired with radiopharmaceuticals such as Tc-99m, Tl-201, or Co-57. These agents are used to visualize biochemical and metabolic processes in cardiac tissue, enabling high-resolution 3D imaging outputs like static, gated, and dynamic representations.
Is the CardioCam Model 9CSY0799 a single-use device, or can it be reused in clinical settings?
The CardioCam Model 9CSY0799 is a reusable device, not intended for single-use. This classification aligns with its design as a durable diagnostic imaging system for radiology settings, allowing repeated use under proper maintenance and regulatory compliance.
What regulatory pathway was followed for the FDA clearance of the CardioCam Model 9CSY0799, and when was it authorized?
The CardioCam Model 9CSY0799 was authorized through the FDA’s 510(k) clearance process, specifically under the traditional pathway, with a clearance number of K011611. It was authorized in 2001 and classified as a Class II medical device, adhering to regulatory standards outlined in 21 CFR 892.1200. The device was reviewed by the Radiology (RA) Advisory Committee.
Does the CardioCam Model 9CSY0799 require any special storage conditions, and is it sterile?
The available data does not specify any special sterility requirements for the CardioCam Model 9CSY0799, nor does it mention MRI safety classifications. As a reusable diagnostic imaging system, proper maintenance and cleaning protocols would be required for clinical use, but no explicit storage conditions (e.g., temperature, humidity) are detailed in the provided information.
What imaging modalities or representations can the CardioCam Model 9CSY0799 generate for cardiac tissue?
The CardioCam Model 9CSY0799 generates high-resolution 3D images of cardiac tissue, including static, gated, and dynamic representations. These modalities help visualize biochemical and metabolic processes in the heart by detecting radioactivity distribution from radiopharmaceuticals like Tc-99m, Tl-201, or Co-57.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K011611