510(k) · Cleared
ClearedAVA (Augmented Vascular Analysis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
See-Mode Technologies Pte, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 16, 2020 as substantially equivalent to K122022 (Atheropoint, LLC, 2012) after a 117-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Sep 16, 2020
- Review
- 117 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021966 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK021966 Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
- 3 generations backK030223 SonocalcSonometric Health, LLC · 2003 · Recalled
- 2 generations backK043360 Imt.LabPie Medical · 2005
- 1 generation backK122022 AtheroedgeAtheropoint, LLC · 2012
- This deviceK201369 AVA (Augmented Vascular Analysis)See-Mode Technologies Pte, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021966 | Q Lab Software | Advanced Technology Laboratories, Inc. | 2002 | — |
| −3 | K030223 | Sonocalc | Sonometric Health, LLC | 2003 | 1 |
| −2 | K043360 | Imt.Lab | Pie Medical | 2005 | — |
| −1 | K122022 | Atheroedge | Atheropoint, LLC | 2012 | — |
| 0 (this device) | K201369 | AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte, Ltd. | 2020 | — |
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 21.6 · 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? (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 |
|---|---|---|---|
| * | K122022 | AtheroedgeSummary page 6…SUBSTANTIAL EQUIVALENCE 1. Predicate Device Manufacturer: AtheroPoint LLC Trade Name: AtheroEdge 510(k) Identifier: K122022 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system… | 2012 |
| † | K180647 | BriefCase | 2018 |
| † | K170568 | CardioLogs ECG Analysis Platform | 2017 |
| † | K163253 | Arterys Cardio DL | 2017 |
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 18 years and passes through 5 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
See-Mode AVA (Augmented Vascular Analysis) is a stand-alone, image processing software for analysis, measurement, and reporting of DICOM-compliant vascular ultrasound images obtained from carotid and lower limb arteries. The analysis includes segmentation of vessels walls and measurement of the intima-media thickness (IMT) of the carotid artery in B-Mode images, finding velocities in Doppler images, and reading annotations on the images. The software…
Read the full statement (148 words)
See-Mode AVA (Augmented Vascular Analysis) is a stand-alone, image processing software for analysis, measurement, and reporting of DICOM-compliant vascular ultrasound images obtained from carotid and lower limb arteries. The analysis includes segmentation of vessels walls and measurement of the intima-media thickness (IMT) of the carotid artery in B-Mode images, finding velocities in Doppler images, and reading annotations on the images. The software generates a vascular ultrasound report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. The client software is designed to run on a standard desktop or laptop computer. See-Mode AVA is intended to be used by trained medical professionals, including but not limited to physicians and medical technicians. The software is not intended to be used as an independent source of medical advice, or to determine or recommend a course of action or treatment for patients.
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/K201369 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201369: AVA (Augmented Vascular Analysis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201369
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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