510(k) · Cleared
ClearedUltraSight AI Guidance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrasight, Inc. · QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Cleared on Jul 24, 2023 as substantially equivalent to DEN190040 (Bay Labs, Inc., 2020) after a 265-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jul 24, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- QJU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190040 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190040 Caption GuidanceBay Labs, Inc. · 2020
- This deviceK223347 UltraSight AI GuidanceUltrasight, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190040 | Caption Guidance | Bay Labs, Inc. | 2020 | — |
| 0 (this device) | K223347 | UltraSight AI Guidance | Ultrasight, Inc. | 2023 | — |
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 QJU? 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 QJU device
- #1 K242807 HeartFocus (V.1.1.1)score 12.1 · 1 generation · 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 |
|---|---|---|---|
| * | DEN190040 | Caption GuidanceSummary page 4…al Intelligence Classification Code: QJU Device class: II Regulation number: 892.2100 Panel: Radiology Predicate Devices: Caption Health’s Caption Guidance (DEN190040) Intended Use / Indications for Use The UltraSight AI Guidance is intended to assist medical professionals (not including e… | 2020 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN190040.
How does its category compare?
All QJU devicesQJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJU
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJU
No recall names QJU since 2007.
Adverse event reports per year · QJU
No MAUDE report names QJU since 2007.
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 | 0 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 199 | 0 | 0 |
| 2026 | 3 | 163 | 0 | — |
What is it indicated for?
The UltraSight Al Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Al Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Al Guidance is indicated for use in two-dimensional transthoracic echocardiography (2D- TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis…
Read the full statement (101 words)
The UltraSight Al Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Al Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Al Guidance is indicated for use in two-dimensional transthoracic echocardiography (2D- TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (APS5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
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/K223347 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223347: UltraSight AI Guidance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223347
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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