AI-Guided Image Acquisition
Helps take a better picture in the first place, by guiding the person holding the probe or tuning the scan.
Every other device type on this list works on an image after it exists. This one works on the moment the image is made, and that is a quietly radical difference.
The best known version guides ultrasound. The software watches the live view and tells the person holding the probe to tilt, slide, or hold, until the view is good enough to keep. Suddenly a nurse can capture a diagnostic heart view without years of training.
Other products in this group tune the scan itself, cleaning up a shorter or lower dose acquisition so it is still readable.
The pattern to notice is that this device type widens who can do the test, rather than changing who reads it. In places short of specialists, that is the bigger lever.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QJU
- FDA name for it
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Rule number
- 21 CFR 892.2100
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask who the guidance was validated on. Software cleared for use by novices was tested with novices, and that is the claim that matters to you.
- Ask what the image quality failure rate looks like, and what happens to a study it cannot get right.
- Ask whether it locks you to particular hardware. Acquisition software often does.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Deski | 2 |
| Caption Health | 2 |
| ThinkSono GmbH | 1 |
| Ultrasight , Ltd. | 1 |
| Caption Health, Inc. | 1 |
| Ultrasight, Inc. | 1 |
| Bay Labs, Inc. | 1 |
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| ThinkSono Guidance | ThinkSono GmbH | July 15, 2026 | K260338 |
| HeartFocus | Deski | June 3, 2026 | K260780 |
| UltraSight Guidance | Ultrasight , Ltd. | December 17, 2025 | K251416 |
| HeartFocus (V.1.1.1) | Deski | April 4, 2025 | K242807 |
| Cardiac Guidance | Caption Health, Inc. | January 15, 2025 | K243065 |
| UltraSight AI Guidance | Ultrasight, Inc. | July 24, 2023 | K223347 |
| Caption Guidance | Caption Health | September 18, 2020 | K201992 |
| Caption Guidance | Caption Health | April 16, 2020 | K200755 |
| Caption Guidance | Bay Labs, Inc. | February 7, 2020 | DEN190040 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.