Panels › Cardiovascular › Product code SDJ · Class 2
Adjunctive Cardiac Amyloidosis Status Indicator
Regulation 870.2200
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SDJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Eko.Ai Pte Ltd. D/B/A Us2.Ai | 1 | 0 |
| InVision Medical Technology Corporation | 1 | 0 |
| Ultromics Limited | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2025 | K250151 | Us2.ca Eko.Ai Pte Ltd. D/B/A Us2.Ai, SG | SDJ |
| May 21, 2025 | K243866 | InVision Precision Cardiac Amyloid InVision Medical Technology Corporation | SDJ |
| Nov 15, 2024 | K240860 | EchoGo Amyloidosis (1.0) Ultromics Limited, GB | SDJ |
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