Cardiac Guidance
by Caption Health, Inc. United States EUDAMED510(k)
510(k) K243065
Product code QJU
Overview
Cardiac Guidance is an Image Acquisition and Optimization Guided by Artificial Intelligence device, designed to enhance the precision of cardiac imaging by leveraging AI-driven algorithms. It assists radiologists and cardiologists in acquiring clearer, more accurate images of the heart, improving diagnostic confidence and workflow efficiency during radiology procedures.
This device is supplied as a software-based solution integrated with imaging systems, intended for use in radiology departments and cardiac imaging centers. It operates as a reusable, non-sterile system, with no specific MRI safety classification noted. The device is authorized under FDA 510K and MDR, with regulatory submissions filed under product code QJU and classified as a Class II medical device. Storage and usage follow standard IT and imaging system protocols as defined by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243065 | Date15 Jan 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QJU
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2100
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Caption Health, Inc.
Questions
How does Cardiac Guidance improve the quality of cardiac imaging compared to traditional methods?
Cardiac Guidance enhances cardiac imaging by using AI-driven algorithms to guide radiologists and cardiologists in acquiring clearer and more accurate images of the heart. This technology helps reduce motion artifacts and improves diagnostic confidence, ultimately streamlining workflow efficiency during radiology procedures.
Is Cardiac Guidance a standalone device, or does it require integration with existing imaging systems?
Cardiac Guidance is supplied as a software-based solution designed to be integrated with existing imaging systems in radiology departments and cardiac imaging centers. It does not function as a standalone device but rather augments the capabilities of compatible imaging platforms.
What type of maintenance or storage requirements does Cardiac Guidance have, and is it reusable?
Cardiac Guidance is a reusable, non-sterile system, meaning it does not require sterile handling or single-use disposal. Storage and usage follow standard IT and imaging system protocols as outlined by the manufacturer, ensuring optimal performance and longevity.
What regulatory pathways does Cardiac Guidance follow, and which advisory committee was involved in its review?
Cardiac Guidance is authorized under both FDA 510K and MDR (Medical Device Regulation) pathways. Its regulatory submission was reviewed by the Radiology (RA) Advisory Committee, and it is classified as a Class II medical device under product code QJU.
Does Cardiac Guidance have any specific safety considerations for use in MRI environments?
The device does not have a specified MRI safety classification, meaning it is not explicitly designed for use within MRI environments. Clinicians should follow standard safety protocols and consult manufacturer guidelines to ensure compatibility and safe operation in any imaging setting.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K243065
- EUDAMED