Panels › Cardiovascular › Product code QME · Class 2
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Regulation 870.2785
4510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QME
| Company | 510(k)s | Recalls |
|---|---|---|
| Oxehealth Limited | 5 | 0 |
| Mindset Medical, Inc. | 2 | 0 |
| PanopticAI Technologies Limited | 2 | 0 |
| Faceheart Corp. | 1 | 0 |
| Nuralogix Corporation | 1 | 0 |
| Presage Security, Inc. d/b/a Presage Technologies, Inc. | 1 | 0 |
| Qompium NV | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K254169 | SmartSpectra Vital Signs Monitor 1.0 Presage Security, Inc. d/b/a Presage Technologies, Inc. | QME |
| Jun 11, 2026 | K253650 | Anura Mobile Core SDK (M1) Nuralogix Corporation, CA | QME |
| May 21, 2026 | K260066 | PanopticAI Vital Signs (1.6.1-22) PanopticAI Technologies Limited, HK | QME |
| Feb 2, 2026 | K251200 | Vital Signs Oxehealth Limited, GB | QME |
| Aug 27, 2025 | K243687 | Vital Signs Oxehealth Limited, GB | QME |
| May 30, 2025 | K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) Mindset Medical, Inc. | QME |
| Dec 23, 2024 | K240890 | PanopticAI Vital Signs PanopticAI technologies Limited, HK | QME |
| Nov 18, 2024 | K241633 | Informed Vital Core Application (IVC App) Mindset Medical, Inc. | QME |
| Jun 7, 2024 | K232804 | FibriCheck Qompium NV, BE | QME |
| Sep 1, 2023 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) Faceheart Corp., KY | QME |
| Apr 29, 2022 | K220899 | Oxehealth Vital Signs Oxehealth Limited, GB | QME |
| Jul 20, 2021 | K211906 | Vital Signs Oxehealth Limited, GB | QME |
| Mar 26, 2021 | DEN200019 | Oxehealth Vital Signs Oxehealth Limited, GB | QME |
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