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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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Cognition Chronicle v2.1 - 00860007318764

No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution

  • 00860007318764 ()


  • Cognitive assessment software

Cognition Snapshot+ 2.1.0 - 00860007318740

No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution

  • 00860007318740 ()


  • Cognitive assessment software

Chronicle Web - 00860007318726

No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution

  • 00860007318726 ()


  • Cognitive assessment software

Cognition Snapshot - 00860007318702

No Description
Qr8 Health Inc
SNP-COG-10
Not in Commercial Distribution

  • 00860007318702 ()


  • Cognitive assessment software

TRAQinform IQ 2 - 00860007104916

No Description
Aiq Global, Inc.
2.x
In Commercial Distribution

  • 00860007104916 ()


  • Radiological PACS software

ProKnow DS - 00860000358705

ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.
PROKNOW, LLC
1.0
In Commercial Distribution

  • 00860000358705 ()


  • Radiological PACS software

Luminopia - 00860007887123

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887123 ()


  • Vision training software

Luminopia - 00860007887109

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887109 ()


  • Vision training software

3D Brachy Application - 00860007402326

3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402326 ()


  • Radiation therapy software

3D Bolus Application - 00860007402319

3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402319 ()


  • Radiation therapy software
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