Cardio-View Display, Cathode-Ray Tube, Medical
by Curlview Igt, LLC 510(k)
Active
510(k) K083321
Overview
The Cardio-View is a Display, Cathode-Ray Tube, Medical, designed for visualizing cardiovascular imaging data. It provides real-time, high-resolution imaging of cardiac structures and functions, supporting diagnostic assessments in clinical settings. The device is classified as a Class II medical device under FDA regulations, requiring premarket notification (510(k)) clearance.
This device is intended for use in hospital or clinical environments, where it is connected to cardiac monitoring systems for display purposes. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure accurate imaging output. The Cardio-View adheres to FDA clearance (K083321) and is regulated under the Display, Cathode-Ray Tube, Medical classification (regulation number 870.2450). No sterility or single-use specifications are indicated in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083321 | Date26 Nov 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Cardio-View
- 510(k) Number
- FDA Product Code
- DXJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Cardio-View Display used for?
The Cardio-View is a cathode-ray tube display specifically designed for visualizing cardiovascular imaging data. It provides real-time, high-resolution imaging of cardiac structures and functions, supporting diagnostic assessments in hospital or clinical environments. This helps clinicians evaluate heart anatomy and function with precision, aiding in accurate diagnosis and treatment planning.
Is the Cardio-View Display a single-use or reusable device?
The Cardio-View is supplied as a reusable medical instrument. Since it is intended for repeated use in clinical settings, proper maintenance and calibration are required to ensure consistent and accurate imaging performance over time. Regular upkeep helps sustain its reliability for ongoing diagnostic procedures.
Does the Cardio-View require sterilization before use?
The regulatory data does not specify sterility requirements for the Cardio-View. As a reusable device, it is not intended to be sterilized like single-use items. Instead, it should be cleaned and maintained according to manufacturer guidelines to prevent contamination and ensure optimal functionality for cardiovascular imaging.
What regulatory approval does the Cardio-View hold?
The Cardio-View has received FDA clearance under the 510(k) premarket notification process, specifically with clearance number K083321. It is classified as a Class II medical device under FDA regulations and falls under the Display, Cathode-Ray Tube, Medical category (regulation number 870.2450). This approval ensures it meets the necessary safety and performance standards for use in clinical settings.
How is the Cardio-View Display connected to cardiac monitoring systems?
The Cardio-View is designed to be integrated with cardiac monitoring systems for display purposes. While the exact connection method is not detailed in the provided data, such devices typically require compatible input interfaces (e.g., analog or digital signals) to receive imaging data from the monitoring system. The manufacturer’s instructions should outline the specific compatibility and setup requirements for proper integration.