510(k) · Cleared
ClearedViz RV/LV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz. Ai, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Aug 29, 2022 as substantially equivalent to K203256 (Imbio, LLC, 2021) after a 137-day review. Its family tree reaches back 8 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 29, 2022
- Review
- 137 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945512 (1995). 17 ancestors in all, the oldest K945428 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 7 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 6 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 5 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 4 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 3 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 2 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 1 generation backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- This deviceK221100 Viz RV/LVViz. Ai, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241112 BriefCase-QuantificationAidoc Medical, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK243779 Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · 2025
- Descendant · 3 generations on · 0 of its ownK242203 BriefCase-QuantificationAidoc Medical, Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K230534BriefCase-QuantificationAidoc Medical, Ltd. · 2023 · cites it directly3descendants
- K241112BriefCase-QuantificationAidoc Medical, Ltd. · 2024 · 2 generations on1descendant
- K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · 2025 · 2 generations on0descendants
- K242203BriefCase-QuantificationAidoc Medical, Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −7 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −6 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −5 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −4 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −3 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −2 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| −1 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| 0 (this device) | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
| +1 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | — |
| +2 | K241112 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2024 | — |
| +2 | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | 2025 | — |
| +3 | K242203 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K203256 | Imbio RV/LV SoftwareSummary page 4…Manufacturer Device Name Application No. Imbio Imbio RV/LV Software K203256 Device Description The Viz RV/LV is a software-only device that uses a locked artificial intelligence machine learning (AI/ML)… | 2021 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230534 | BriefCase-Quantification | 2023 | 3 |
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 27 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K230534 (Aidoc Medical, Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K203256.
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?
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Viz RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The Viz RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221100: Viz RV/LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221100
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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