Transparency Registry · product code QJU
AI-guided image acquisition AI: all 9 FDA clearances
Image Acquisition And/Or Optimization Guided By Artificial Intelligence. AI that guides the acquisition or optimization of medical images at the point of capture, including cardiac ultrasound guidance. This list is generated from openFDA public records and refreshes automatically every week — bookmark it and it stays current.
| Device | Applicant | Decision date |
|---|---|---|
| ThinkSono Guidance | ThinkSono GmbH | 2026-07-15 |
| HeartFocus | Deski | 2026-06-03 |
| UltraSight Guidance | Ultrasight , Ltd. | 2025-12-17 |
| HeartFocus (V.1.1.1) | Deski | 2025-04-04 |
| Cardiac Guidance | Caption Health, Inc. | 2025-01-15 |
| UltraSight AI Guidance | Ultrasight, Inc. | 2023-07-24 |
| Caption Guidance | Caption Health | 2020-09-18 |
| Caption Guidance | Caption Health | 2020-04-16 |
| Caption Guidance | Bay Labs, Inc. | 2020-02-07 |
Facts only, sourced per entry. Listing is not evaluation. Full methodology on the registry index. Evaluating this category? The due-diligence checklist and free instruments are where buyers start.