# K082526: Cardio Vue Quantitative Analysis (CVQ)

- Pathway: 510(k) (Traditional)
- Applicant: Mri Cardiac Services, Incorporated
- Decided: Jan 5, 2009 after 125 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940172 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 3.
- K994282: Mri- Flow Analytical Software Package, Medis Medical Imaging Systems BV (2000) Summary page 3.

## Indications for use
CardioVue Quantitative AnalysisTM is an integrated software component of the CardioVue (K060840) medical image management device that analyzes DICOM-compliant cardiovascular images acquired from MRI scanners and produces reports. CardioVue Quantitative Analysis TM assists qualified cardiologist, radiologist or other licensed professional healthcare practitioners in making their diagnosis by performing functional and blood flow analysis and in reporting their patient study findings. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Source page: https://510kreport.com/device/K082526
Methodology: https://510kreport.com/methodology