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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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No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630015 ()


  • Laboratory analyser operation system software IVD
No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630008 ()


  • Laboratory analyser operation system software IVD
Microwave Ablation Generator
Canyon Medical Inc.
KY-2100A
In Commercial Distribution

  • 06954414674453 ()


  • Microwave hyperthermia system
Microwave Ablation Generator
Canyon Medical Inc.
KY-2000A
In Commercial Distribution

  • 06954414610024 ()


  • Microwave hyperthermia system
XScribe/RScribe Server - version 6, current software CD; Software kit; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094257748 ()
XSERV-6AA-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer
Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
iGUIDE is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.
3C-Medical Intelligence GmbH
P10603-111-223
In Commercial Distribution

  • 04056719002190 ()
P10603-111

  • Accelerator system table, powered
InnoSight Diagnostic Ultrasound System
QISDA CORPORATION
989605486132
In Commercial Distribution

  • 04719873000517 ()


  • General-purpose ultrasound imaging system
InnoSight Diagnostic Ultrasound System
QISDA CORPORATION
989605486131
In Commercial Distribution

  • 04719873000333 ()


  • General-purpose ultrasound imaging system
InnoSight Diagnostic Ultrasound System
QISDA CORPORATION
989605486131
In Commercial Distribution

  • 04719873000319 ()


  • General-purpose ultrasound imaging system
InnoSight Diagnostic Ultrasound System
QISDA CORPORATION
989605463521
In Commercial Distribution

  • 04719873000265 ()


  • General-purpose ultrasound imaging system
InnoSight Diagnostic Ultrasound System
QISDA CORPORATION
989605463521
In Commercial Distribution

  • 04719873000258 ()


  • General-purpose ultrasound imaging system
InnoSight Diagnostic Ultrasound System
QISDA CORPORATION
989605463521
In Commercial Distribution

  • 04719873000012 ()


  • General-purpose ultrasound imaging system
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution

  • 00850012642015 ()


  • MRI image interpretive software
AI SaMD for prostate cancer.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution

  • 00850012642008 ()


  • MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.9.0
In Commercial Distribution

  • 00850012642084 ()


  • MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.8.0
In Commercial Distribution

  • 00850012642077 ()


  • MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.7.0
In Commercial Distribution

  • 00850012642060 ()


  • MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.6.0
In Commercial Distribution

  • 00850012642053 ()


  • MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.5.0
In Commercial Distribution

  • 00850012642046 ()


  • MRI image interpretive software
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