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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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UltraWEB - 00860001148565

DICOM Viewer
ULTRARAD CORPORATION
6.0.0.0
In Commercial Distribution

  • 00860001148565 ()


  • Radiological PACS software

UltraPREFETCH - 00860001148558

UltraPREFETCH automatically retrieves studies and sends to any DICOM client, on a rule based criteria.
ULTRARAD CORPORATION
3.0.3.2
In Commercial Distribution

  • 00860001148558 ()


  • Radiological PACS software

UltraMEDIA - 00860001148541

DICOM file import tool
ULTRARAD CORPORATION
1.0.0.0
In Commercial Distribution

  • 00860001148541 ()


  • Radiological PACS software

UltraARCHIVE - 00860001148534

DICOM Storage
ULTRARAD CORPORATION
3.0.4.9
In Commercial Distribution

  • 00860001148534 ()


  • Radiological PACS software

UltraGATEWAY - 00860001148527

DICOM Router
ULTRARAD CORPORATION
3.0.4.9
In Commercial Distribution

  • 00860001148527 ()


  • Radiological PACS software

UltraDISTRIBUTOR - 00860001148510

Allows sites a methodology to securely deliver electronic results and images to their referring physicians
ULTRARAD CORPORATION
1.0.0.2
In Commercial Distribution

  • 00860001148510 ()


  • Radiological PACS software

UltraVISION - 00860001148503

Clinical image viewer
ULTRARAD CORPORATION
2.0.0.0
In Commercial Distribution

  • 00860001148503 ()


  • Radiological PACS software

IRIS - 00860001130508

The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam.
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
3.0
In Commercial Distribution

  • 00860001130508 ()


  • Ophthalmology PACS software

SmartCeph - 00860001048506

DI DLS
Ortho2, LLC
6.1.1
In Commercial Distribution

  • 00860001048506 ()


  • Radiological PACS software

Luminopia - 00860007887116

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887116 ()


  • Vision training software

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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