510(k) · Cleared
ClearedQIR Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Casis Cardiac Simulation & Imaging Software · QIH Automated Radiological Image Processing Software
Cleared on Sep 30, 2022 as substantially equivalent to K163076 (Medviso AB, 2017) after a 493-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Sep 30, 2022
- Review
- 493 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900889 (1990). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK900889 Magnetic Resonance Diagnostic Device AccessoriesSiemens Medical Solutions USA, Inc. · 1990
- 5 generations backK973799 Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc. · 1998
- 4 generations backK061368 Diagnosoft HarpDiagnosoft, Inc. · 2006
- 3 generations backK100352 Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010
- 2 generations backK111833 VirtueDiagnosoft, Inc. · 2011
- 1 generation backK163076 Segment CMRMedviso AB · 2017
- This deviceK211611 QIR SuiteCasis Cardiac Simulation & Imaging Software · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900889 | Magnetic Resonance Diagnostic Device Accessories | Siemens Medical Solutions USA, Inc. | 1990 | — |
| −5 | K973799 | Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −4 | K061368 | Diagnosoft Harp | Diagnosoft, Inc. | 2006 | — |
| −3 | K100352 | Diagnosoft Harp Model 2.06 | Diagnosoft, Inc. | 2010 | — |
| −2 | K111833 | Virtue | Diagnosoft, Inc. | 2011 | — |
| −1 | K163076 | Segment CMR | Medviso AB | 2017 | — |
| 0 (this device) | K211611 | QIR Suite | Casis Cardiac Simulation & Imaging Software | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163076 | Segment CMRSummary page 5…lass II Product code: QIH Submission number: K211611 3. Predicate device QIR Suite is substantially equivalent to Segment CMR of Medviso AB (K163076). This predicate is under the same regulation as QIR Suite (Table 1). Segment CMR is a software with functionalities to analyze c… | 2017 |
| † | K141480 | CVI42 | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K163076.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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…
Read the full statement (254 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211611 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211611: QIR Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211611
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026