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Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543449 ()
FICOBC
- Custom-made orthopaedic/craniofacial surgical guide
Maxillomandibular Anatomic Diagnostic Model CL
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543432 ()
MAPMMCL
- Custom-made organ/bone anatomy model
Patient-Specific Maxillofacial/midface implant-Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543425 ()
BETMCT
- Custom-made cranial bone prosthesis
Patient-Specific Maxillary Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543418 ()
BEACMXT
- Custom-made cranial bone prosthesis
Patient-Specific Mandible Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543401 ()
BEACMT
- Custom-made cranial bone prosthesis
ATOM Disposable Skin Temp Probe BOX/20
Atom Medical Usa, LLC
NF-023T
In Commercial Distribution
- 00860007476310 ()
- 00860007476303 ()
- General-purpose patient temperature probe, single-use
The CogNet AI-MT is a standalone software medical device for screening FFDM mammograms. This software is a triage device that allows the result to be prioritized for viewing by a qualified radiologist.
Medcognetics Inc
MT
In Commercial Distribution
- 00860007434709 ()
- X-ray image interpretive software
No Description
Anumana, Inc.
v 2.3.0 (1010)
- Cardiopulmonary physiological parameter analysis software
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
TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).
Adaptiiv Medical Technologies Inc
N/A
In Commercial Distribution
- 10860007402385 ()
- 00860007402388 ()
- Radiation therapy bolus, single-use