QJU
- Product code
- QJU
- Device name
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2100
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
FDA classification definition
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260338 | 2026-07-15 | ThinkSono GmbH | ThinkSono Guidance | |
| K260780 | 2026-06-03 | Deski | HeartFocus | |
| K251416 | 2025-12-17 | Ultrasight , Ltd. | UltraSight Guidance | |
| K242807 | 2025-04-04 | Deski | HeartFocus (V.1.1.1) | FDA |
| K243065 | 2025-01-15 | Caption Health, Inc. | Cardiac Guidance | FDA |
Official FDA classification page: QJU
Classification and pathway per current FDA publications. Data from openFDA (CC0).