Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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NANO-X AI LTD
1.1
In Commercial Distribution

  • 07290018016145 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
1.1
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  • 07290018016138 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
1.1
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  • 07290018016114 ()


  • Radiology DICOM image processing application software
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1.0
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  • 07290018016107 ()


  • Radiology DICOM image processing application software
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1.0
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  • 07290018016091 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
1.0
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  • 07290018016084 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
2.0.0
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  • 07290018016077 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
2.2
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  • 07290018016060 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
3.0.0
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  • 07290018016053 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
1.0.0
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  • 07290018016046 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
2.1.3
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  • 07290018016039 ()


  • Radiology DICOM image processing application software
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2.0.5
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  • 07290018016022 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
1.0.6
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  • 07290018016015 ()


  • Radiology DICOM image processing application software
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NANO-X AI LTD
3.0.0
Not in Commercial Distribution

  • 07290018016008 ()


  • Radiology DICOM image processing application software
Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.
Tempus AI, Inc.
2
In Commercial Distribution

  • 00860011843610 ()


  • Cardiopulmonary physiological parameter analysis software
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software
FIBEROPTIC LIGHT CABLE ADAPTER FOR AI
Avalign Technologies, Inc.
72-52310
In Commercial Distribution

  • 00190776208738 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
AI Female Fitting Ass'y nonperm clips
Avalign Technologies, Inc.
M152332
In Commercial Distribution

  • 00190776189648 ()


  • Electrical-only medical device connection cable, reusable
AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution

  • 10806378054716 ()


  • Orthopaedic implant/instrument assembling device
SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution

  • 00763000504533 ()


  • Implantable cardiac device management application software
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