510(k) · Cleared
ClearedAngioWaveNet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angiowave Imaging, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 10, 2025 as substantially equivalent to K212074 (Claripi, Inc., 2021) after a 258-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Sep 10, 2025
- Review
- 258 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922470 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 4 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 3 generations backK160852 ZiaZetta Medical Technologies, LLC · 2016
- 2 generations backK183460 ClariCT.AIClaripi, Inc. · 2019
- 1 generation backK212074 ClariCT.AIClaripi, Inc. · 2021
- This deviceK244002 AngioWaveNetAngiowave Imaging, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −5 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −4 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −3 | K160852 | Zia | Zetta Medical Technologies, LLC | 2016 | — |
| −2 | K183460 | ClariCT.AI | Claripi, Inc. | 2019 | — |
| −1 | K212074 | ClariCT.AI | Claripi, Inc. | 2021 | — |
| 0 (this device) | K244002 | AngioWaveNet | Angiowave Imaging, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K212074 | ClariCT.AISummary page 5…ame: Medical image management and processing system Regulatory Class: II Product Code: QIH, Secondary Product Code OWB 2. Equivalent legally marketed devices: K212074 Trade/Device Name: ClariCT.AI Manufacturer: ClariPi USA Inc. Regulation Number: 21 CFR 892.2050 Regulation Na… | 2021 |
| † | K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | 2023 |
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 33 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K212074.
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. 2025, 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?
AngioWaveNet is indicated for use by qualified physicians or under their supervision to aid in the analysis and interpretation of X-ray coronary angiographic cines. AngioWaveNet is intended for use in adults during X-ray coronary angiographic imaging procedures as a clinically useful complement to the viewing of standard angiographic cines acquired during diagnostic coronary angiography procedures. AngioWaveNet software is intended for use to enhance the visibility of blood vessels, vascular structures, and related anatomical features within angiographic images, which may be clinically useful to the treating physician
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K244002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K244002: AngioWaveNet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K244002
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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