510(k) · Cleared
ClearediTFlow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Flow Design, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 12, 2023 as substantially equivalent to K141480 (Circle Cardiovascular Imaging, Inc., 2014) and 1 other predicate after a 233-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- May 12, 2023
- Review
- 233 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940172 (1994). 7 ancestors in all, the oldest K924605 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 3 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 2 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 1 generation backK082628 CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc. · 2008
- This deviceK222854 iTFlowCardio Flow Design, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK240385 VINTMediimg Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K240385VINTMediimg Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −3 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −2 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −1 | K082628 | CMR42 Cardiac Mri Imaging System, 2.1.23 | Circle Cardiovascular Imaging, Inc. | 2008 | — |
| 0 (this device) | K222854 | iTFlow | Cardio Flow Design, Inc. | 2023 | — |
| +1 | K240385 | VINT | Mediimg Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K141480 | CVI42Summary page 4…LLZ Regulatory Class II 3. Predicate Device Primary Predicate Device: Proprietary Name cvi42 Premarket Notification K141480 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 P… | 2014 |
| * | K082628 | CMR42 Cardiac Mri Imaging System, 2.1.23Summary page 4…LLZ Regulatory Class II Secondary Predicate Device: Proprietary Name cmr42 Premarket Notification K082628 Classification Name 21 CFR 892.2050) Regulation Number 21 CFR 892.2050… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240385 | VINT | 2024 | 0 |
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 29 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K240385 (Mediimg Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K141480.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The iTFlow software will be utilized in situations where visualization of blood flow in a heart and its major vessels are required for a cardiac diagnosis. iTFlow allows for the viewing, post-processing, and the quantitative evaluation of cardiovascular MRI data (in DIRECTOR-compliant format) It enables: - The import of DICOM-compliant MR Images. - The support of a clinical diagnosis by the quantitative analysis of the imported images. - Quantitative…
Read the full statement (168 words)
The iTFlow software will be utilized in situations where visualization of blood flow in a heart and its major vessels are required for a cardiac diagnosis. iTFlow allows for the viewing, post-processing, and the quantitative evaluation of cardiovascular MRI data (in DIRECTOR-compliant format)
It enables:
- The import of DICOM-compliant MR Images.
- The support of a clinical diagnosis by the quantitative analysis of the imported images.
- Quantitative measurement of the size, area, blood flow, volume and mass of the heart and adjacent vessels.
-Advanced correction options such as offset correction, background phase correction, and anti-aliasing.
-Data visualization as a graph or output as an image or numerical data.
iTFlow software will assist clinicians with proper training in cardiac treatment decision making and in providing a conclusive diagnosis for patients. It is intended to analyze cardiovascular MRI image data, that are acquired via electrocardiogram gated acquisition, gradient echo cine sequence, and phase contrast time-resolved multi-slice sequence, without any-contrast medium for MR angiography. Patient populations are not restricted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222854: iTFlow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222854
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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