Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Regulation 892.2100
4510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QJU
| Company | 510(k)s | Recalls |
|---|---|---|
| Caption Health | 3 | 0 |
| Deski | 2 | 0 |
| Ultrasight , Ltd. | 2 | 0 |
| Bay Labs, Inc. | 1 | 0 |
| GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 1 | 0 |
| ThinkSono GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K261042 | Lung Guidance GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | QJU |
| Jul 15, 2026 | K260338 | ThinkSono Guidance ThinkSono GmbH, DE | QJU |
| Jun 3, 2026 | K260780 | HeartFocus Deski, FR | QJU |
| Dec 17, 2025 | K251416 | UltraSight Guidance Ultrasight , Ltd., IL | QJU |
| Apr 4, 2025 | K242807 | HeartFocus (V.1.1.1) Deski, FR | QJU |
| Jan 15, 2025 | K243065 | Cardiac Guidance Caption Health, Inc. | QJU |
| Jul 24, 2023 | K223347 | UltraSight AI Guidance Ultrasight, Inc., IL | QJU |
| Sep 18, 2020 | K201992 | Caption Guidance Caption Health | QJU |
| Apr 16, 2020 | K200755 | Caption Guidance Caption Health | QJU |
| Feb 7, 2020 | DEN190040 | Caption Guidance Bay Labs, Inc. | QJU |
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