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| Product | Model | Company | Device type |
|---|---|---|---|
| ActuviActuvi LLCPatient health record information system application software | 1.0 | Actuvi LLC | Patient health record information system application software |
| AHI SystemFifth Eye, Inc.Clinical decision management support software | 2 | Fifth Eye, Inc. | Clinical decision management support software |
| Analytic for Hemodynamic InstabilityFifth Eye, Inc.Clinical decision management support software | P1 | Fifth Eye, Inc. | Clinical decision management support software |
| Biovitals Analytics EngineBiofourmis Singapore Pte. Ltd.Physiologic monitor-installed software | 2.0 | Biofourmis Singapore Pte. Ltd. | Physiologic monitor-installed software |
| CipherOx CRIFlashback Technologies, Inc.Pulse oximeter probe, single-use | CRI | Flashback Technologies, Inc. | Pulse oximeter probe, single-use |
| EchoGoUltromics LimitedCardiac mapping system application software | Amyloidosis 1.0 | Ultromics Limited | Cardiac mapping system application software |
| ETIOMETRY PLATFORMEtiometry Inc.Clinical decision management support software | 2 | Etiometry Inc. | Clinical decision management support software |
| NAVOYCDSAlgoDx ABClinical decision management support software | 1.0 | AlgoDx AB | Clinical decision management support software |
| Neko HealthNeko Health ABPatient monitoring system module, multifunction | Echo-2 | Neko Health AB | Patient monitoring system module, multifunction |
| PMD-200 SystemMedasense Biometrics LtdAnalgesia nociception index monitoring system | PMD200-2 | Medasense Biometrics Ltd | Analgesia nociception index monitoring system |
| prolaio eVO2peak ModuleProlaio, Inc.Electrocardiography monitoring system receiver | 1.0 | Prolaio, Inc. | Electrocardiography monitoring system receiver |
| prolaio Personalized Physiology Analytics Engine Software (PPA)Prolaio, Inc.Electrocardiography monitoring system receiver | 1.0 | Prolaio, Inc. | Electrocardiography monitoring system receiver |
| Sepsis ImmunoScorePrenosis, Inc.Clinical decision management support software IVD | 1.6.1 | Prenosis, Inc. | Clinical decision management support software IVD |
| SignalHFImplicity Inc.Cardiology information system application software | V1.0.2 | Implicity Inc. | Cardiology information system application software |
| T3 PLATFORM SOFTWAREEtiometry Inc.Clinical decision management support software | 2 | Etiometry Inc. | Clinical decision management support software |
| Vios Monitoring System Mobile ApplicationMurata Vios, Inc.Cardiac arrhythmia monitoring system | VMM2050 Mobile Application | Murata Vios, Inc. | Cardiac arrhythmia monitoring system |
| Vital SignsOxehealth LimitedNear-infrared camera vital sign measurement software | 2 | Oxehealth Limited | Near-infrared camera vital sign measurement software |
| Vital-TracMindset Medical Inc.Camera application software | PROEMEMB | Mindset Medical Inc. | Camera application software |
| Vital-TracMindset Medical Inc.Camera application software | RROEMEMB | Mindset Medical Inc. | Camera application software |
| Vivio System EKG PatchVentric HealthElectrocardiograph, professional, single-channel | VP 1.0 | Ventric Health | Electrocardiograph, professional, single-channel |
| Viz HCMViz.ai, Inc.Cardiopulmonary physiological parameter analysis software, professional-only | Viz HCM Software | Viz.ai, Inc. | Cardiopulmonary physiological parameter analysis software, professional-only |