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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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MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
M2S, INC.
4.x
Not in Commercial Distribution

  • B119PREVIEW0 ()


  • Radiology information system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314170 ()


  • Ultrasound imaging system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314160 ()


  • Ultrasound imaging system application software
No Description
SIRIS MEDICAL, INC.
ISS100S
Not in Commercial Distribution

  • B244ISS100S0 ()
ISS100S

  • Radiation therapy software
ClearRead CT Console
Riverain Technologies, Inc.
1.0.2
In Commercial Distribution

  • M722Z19154V191210 ()


  • Radiological PACS software
ClearRead CT Console
Riverain Technologies, Inc.
1.0.1.32
Not in Commercial Distribution

  • M722Z19122V191210 ()


  • Radiological PACS software
ClearRead CT Console
Riverain Technologies, Inc.
1.0.0.26
Not in Commercial Distribution

  • M722Z19077V190530 ()


  • Radiological PACS software
ClearRead Xray Docker Compare
Riverain Technologies, Inc.
5.0.0
In Commercial Distribution

  • M722XD25114T250640 ()


  • Radiological PACS software
ClearRead Xray Docker Enhance
Riverain Technologies, Inc.
4.0.0
In Commercial Distribution

  • M722XD25114E250640 ()


  • Radiological PACS software
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