8 devices · 6 companies · 2020 to 2026
Product code QJU: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
8 devices under product code QJU, 2020 to 2026, from 6 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 8 here), the regulation, and MAUDE report counts by product code.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence. 21 CFR 892.2100, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| HeartFocusK260780 · 510(k) | Deski | Radiology | database entry | |
| UltraSight GuidanceK251416 · 510(k) | Ultrasight , Ltd. | Radiology | database entry | |
| HeartFocusK242807 · 510(k) | Deski | Radiology | database entry | |
| Cardiac GuidanceK243065 · 510(k) | Caption Health, Inc. | Radiology | database entry | |
| UltraSight AI GuidanceK223347 · 510(k) | UltraSight Inc. | Radiology | database entry | |
| Caption GuidanceK201992 · 510(k) | Caption Health | Radiology | database entry | |
| Caption GuidanceK200755 · 510(k) | Caption Health | Radiology | database entry | |
| Caption GuidanceDEN190040 · De Novo | Bay Labs, Inc. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.