QJU
9 FDA 510(k) clearances · Product code
163 daysmedian time to decision
265 days90th percentile
9clearances measured
FDA profile
- Official device name
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2100
- Medical specialty
- Radiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ThinkSono Guidance (K260338) | ThinkSono GmbH | 2026-07-15 |
| HeartFocus (K260780) | Deski | 2026-06-03 |
| UltraSight Guidance (K251416) | Ultrasight , Ltd. | 2025-12-17 |
| HeartFocus (V.1.1.1) (K242807) | Deski | 2025-04-04 |
| Cardiac Guidance (K243065) | Caption Health, Inc. | 2025-01-15 |
| UltraSight AI Guidance (K223347) | Ultrasight, Inc. | 2023-07-24 |
| Caption Guidance (K201992) | Caption Health | 2020-09-18 |
| Caption Guidance (K200755) | Caption Health | 2020-04-16 |
| Caption Guidance (DEN190040) | Bay Labs, Inc. | 2020-02-07 |
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Every clearance here is in the API, with alerts when new ones post.