QJU — Image Acquisition And/Or Optimization Guided By Artificial Intelligence Class II
FDA product code QJU covers "Image Acquisition And/Or Optimization Guided By Artificial Intelligence", a Class II medical device regulated under 21 CFR 892.2100. Submissions are reviewed by the Radiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJU
- Device Class
- Class II
- Regulation Number
- 892.2100
- Submission Type
- 510(k)
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261042 | Ge Medical Systems Ultrasound And Primary Care Diagnostics | Lung Guidance | Oct 2, 2026 |
| K260338 | Thinksono | ThinkSono Guidance | Jul 15, 2026 |
| K260780 | Deski | HeartFocus | Jun 3, 2026 |
| K251416 | Ultrasight | UltraSight Guidance | Dec 17, 2025 |
| K242807 | Deski | HeartFocus (V.1.1.1) | Apr 4, 2025 |
| K243065 | Caption Health | Cardiac Guidance | Jan 15, 2025 |
| K223347 | Ultrasight | UltraSight AI Guidance | Jul 24, 2023 |
| K201992 | Caption Health | Caption Guidance | Sep 18, 2020 |
| K200755 | Caption Health | Caption Guidance | Apr 16, 2020 |
| DEN190040 | Bay Labs | Caption Guidance | Feb 7, 2020 |