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 9 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
- 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 |
|---|---|---|---|
| K260338 | thinksono | ThinkSono Guidance | July 15, 2026 |
| K260780 | deski | HeartFocus | June 3, 2026 |
| K251416 | ultrasight | UltraSight Guidance | December 17, 2025 |
| K242807 | deski | HeartFocus (V.1.1.1) | April 4, 2025 |
| K243065 | caption health | Cardiac Guidance | January 15, 2025 |
| K223347 | ultrasight | UltraSight AI Guidance | July 24, 2023 |
| K201992 | caption health | Caption Guidance | September 18, 2020 |
| K200755 | caption health | Caption Guidance | April 16, 2020 |
| DEN190040 | bay labs | Caption Guidance | February 7, 2020 |