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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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TOMTEC-ARENA - 04260361440181

TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images.
TOMTEC Imaging Systems GmbH
TTA2.50
In Commercial Distribution

  • 04260361440181 ()


  • Radiological PACS software

TOMTEC-ARENA - 04260361440174

TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
TOMTEC Imaging Systems GmbH
TTA2.41
In Commercial Distribution

  • 04260361440174 ()


  • Radiological PACS software

TOMTEC-ARENA - 04260361440167

TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
TOMTEC Imaging Systems GmbH
TTA2.40
Not in Commercial Distribution

  • 04260361440167 ()


  • Radiological PACS software

IMAGE-ARENA - 04260361440150

The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool. IMAGE-ARENA is not intended to be used for reading of mammography images.
TOMTEC Imaging Systems GmbH
IA4
Not in Commercial Distribution

  • 04260361440150 ()


  • Radiological PACS software

TOMTEC-ARENA - 04260361440143

TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images.
TOMTEC Imaging Systems GmbH
TTA2
In Commercial Distribution

  • 04260361440143 ()


  • Radiological PACS software

Prelude - 04260308110078

The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron. It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device. The machine parameters are not intended to be used for direct control for the radiation device. Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution

  • 04260308110078 ()


  • Radiation therapy software

ChestView US - 03770020839092

No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839092 ()


  • Radiological PACS software

BoneView - 03770020839085

No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software

BoneView - 03770020839009

No Description
GLEAMER
1.X-US
In Commercial Distribution

  • 03770020839009 ()


  • Radiological PACS software

ART-Plan - 03770019940006

The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights.
THERAPANACEA
v.1.10.0
In Commercial Distribution

  • 03770019940006 ()


  • Radiation therapy software

inHEART Models Explorer - 03770019599112

inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART Models Shaper. inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v3.0.0
In Commercial Distribution

  • 03770019599112 ()
NA

  • Radiological PACS software

inHEART MODELS Explorer - 03770019599099

inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART MODELS Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.8.0
Not in Commercial Distribution

  • 03770019599099 ()


  • Radiological PACS software

inHEART Models Explorer - 03770019599020

inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.5.0
Not in Commercial Distribution

  • 03770019599020 ()


  • Radiological PACS software

inHEART Models Explorer - 03770019599006

inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs. inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). Clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.2.1
Not in Commercial Distribution

  • 03770019599006 ()


  • Radiological PACS software

QuantX - B80731

QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution

  • B80731 ()
3

  • Radiological PACS software

QuantX - B80721

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software

QuantX - B80711

QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution

  • B80711 ()
1

  • Radiological PACS software

TechCare Trauma - 03770024774047

No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software

LMS-Liver - 03760263520024

LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
MEDIAN TECHNOLOGIES
6.0
In Commercial Distribution

  • 03760263520024 ()


  • Radiological PACS software

LMS-Lung/TRACK - 03760263520017

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports.
MEDIAN TECHNOLOGIES
6.0
In Commercial Distribution

  • 03760263520017 ()


  • Radiological PACS software

AVIEW CAC - 08800025300367

No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300367 ()


  • Radiological PACS software

AVIEW - 08800025300299

No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300299 ()


  • Radiological PACS software

AVIEW CAC - 08800025300237

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300237 ()


  • Radiological PACS software

AVIEW Lung Nodule CAD - 08800025300176

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300176 ()


  • Radiological PACS software

AVIEW - 08800025300152

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300152 ()


  • Radiological PACS software

AVIEW RT ACS - 08800025300145

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300145 ()


  • Radiological PACS software

AVIEW LCS - 08800025300084

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300084 ()


  • Radiological PACS software

AVIEW - 08800025300077

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300077 ()


  • Radiological PACS software

AVIEW LCS - 08800025300039

No Description
CORELINE SOFT CO.,LTD.
1.0
In Commercial Distribution

  • 08800025300039 ()


  • Radiological PACS software

AVIEW Modeler - 08800025300022

No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300022 ()


  • Radiological PACS software

AVIEW - 08800025300015

No Description
CORELINE SOFT CO.,LTD.
1.0
In Commercial Distribution

  • 08800025300015 ()


  • Radiological PACS software

NA - 08717213053700

Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170018-00
In Commercial Distribution

  • 08717213053700 ()
  • 08717213054004 ()
  • 08717213053991 ()


  • Radiation therapy software

NA - 08717213051881

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-05
Not in Commercial Distribution

  • 08717213051881 ()


  • Radiation therapy software

NA - 08717213051843

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-24
Not in Commercial Distribution

  • 08717213051843 ()


  • Radiation therapy software

NA - 08717213051782

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-04
Not in Commercial Distribution

  • 08717213051782 ()


  • Radiation therapy software

NA - 08717213051775

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-23
Not in Commercial Distribution

  • 08717213051775 ()


  • Radiation therapy software

NA - 08717213051294

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213051294 ()


  • Radiation therapy software

Radiation Planning Assistant (RPA) - 00040695000008

The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
The University of Texas M. D. Anderson Cancer Center
1.0.0.5
In Commercial Distribution

  • 00040695000008 ()


  • Radiation therapy software

3DIEMME RealGUIDE - 08050038830058

Full integrated planning, guide design and prosthesis modelling
3DIEMME SRL
RealGUIDE CAD+
In Commercial Distribution

  • 08050038830058 ()


  • CAD/CAM software

3DIEMME RealGUIDE - 08050038830041

Prosthesis modelling (stand-alone)
3DIEMME SRL
RealGUIDE CAD
In Commercial Distribution

  • 08050038830041 ()


  • CAD/CAM software
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