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SuRgical Planner (SRP) BrainStorm Desktop System
SURGICAL THEATER LLC
BrainStorm
In Commercial Distribution
- 00860003884119 ()
- Surgical simulation system
SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SyncAR
In Commercial Distribution
- 00860003884102 ()
- Surgical planning/navigation-enhancement system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 700
In Commercial Distribution
- 00860002736037 ()
Provider 700
- Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 790
In Commercial Distribution
- 00860002736020 ()
Provider 790
- Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 680
In Commercial Distribution
- 00860002736013 ()
Provider 680
- Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
ProAlert 570
In Commercial Distribution
- 00860002736006 ()
ProAlert 570
- Nurse call system
SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
Big Health Inc.
v1
In Commercial Distribution
- 00860008033024 ()
- Mental health/function therapeutic software, screen-viewed
The Low Ejection Fraction AI-ECG Algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds of a single 12-lead ECG acquisition, and within seconds provides a prediction of likelihood of LVEF (ejection fraction less than or equal to 40%) to third party software. The results are displayed by the thirdparty software on a device such as a smartphone, tablet, or PC. The Low Ejection Fraction AIECG Algorithm was trained to predict Low LVEF using positive and control cohorts, and the prediction of Low LVEF in patients is generated using defined conditions and covariates.
The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.
Anumana, Inc.
v.2.2.0 (1010)
In Commercial Distribution
- 00860007426407 ()
- Cardiopulmonary physiological parameter analysis software
No Description
DIGIRAD CORPORATION
Mobile
In Commercial Distribution
- 00850816007096 ()
- SPECT system, annular detector array
No Description
DIGIRAD CORPORATION
Mobile XPOD
In Commercial Distribution
- 00850816007089 ()
- SPECT system, annular detector array