# K211611: QIR Suite

- Pathway: 510(k) (Traditional)
- Applicant: Casis Cardiac Simulation & Imaging Software
- Decided: Sep 30, 2022 after 493 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 6 generations back to K900889 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163076: Segment CMR, Medviso AB (2017) Summary page 5.

## Indications for use
QIR Suite is intended to be used for viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM (Digital Imaging and Communication in Medicine) Standard format. The software has been validated for use on adult patients. QIR Suite comprises QIR-MR for analysis of MR images. QIR-MR is composed of a viewer and analysis modules, and uses user inputs, standard algorithms, and/or automated deep learning detection algorithms. QIR Suite support the following functionalities: * Receive, store, transmit, post-process, display, and manipulate medical MR/CT images in the DICOM format (all transfer syntaxes supported including JPEG2000). * Client/server functionalities to connect to a PACS (Picture Archiving and Communication System), to a HL7 server. * Visualization of 2D and 2D + time of single or multiple MR datasets. * Segmentation of regions of interest. * Measurement of distances and areas. * Cardiac function MR analyses for the four chambers, including ejection fraction assessment, local myocardial mass, diastolic function, thickness and thickening. * 2D Flow studies. Each module generates an automated report of the analysis. QIR Suite allows connection and storage of analyses on a PACS and on a HL7 server. The software is not intended for use by patients, but rather by qualified medical professionals, experienced in examining and interpreting cardiovascular MR images to obtain diagnostic information as part of a comprehensive diagnostic decision-making process. QIR Suite cannot replace the diagnosis of a qualified practitioner and cannot be regarded as a sole medical point-of-view. The final diagnosis is the sole responsibility of the practitioner.

Source page: https://510kreport.com/device/K211611
Methodology: https://510kreport.com/methodology