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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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SecondLook Digital (SLD) - 00858012005007

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005007 ()
DS0206

  • Basic diagnostic x-ray system application software

NA - 00643169518957

PROG 8835 PERSONAL THERAPY MGR ROHS
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169518957 ()


  • Infusion pump programmer

NA - 00643169512948

PROG 8835 PERSONAL THERAPY 60601-11
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169512948 ()


  • Infusion pump programmer

N/A - 00643169771048

SW APP A820 TDD PATIENT PROG
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00643169771048 ()


  • Infusion pump programmer

N/A - 00643169771031

SW APP A810 TDD CLINICIAN PROG
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00643169771031 ()


  • Infusion pump programmer

NA - 00643169974791

PROG 8835 PERSONAL THERAPY MGR GRC
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169974791 ()


  • Infusion pump programmer

SaeboRejoyce - 00850331006567

Virtual-display arm rehabilitation system
SAEBO, INC.
SaeboRejoyce
In Commercial Distribution

  • 00850331006567 ()
K4-RJ-10---1

  • Virtual-display arm rehabilitation system, non-gravity-compensating

VIDA Insights - 00852426007022

VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution

  • 00852426007022 ()


  • CT system application software

LungPrint - 00852426007015

LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution

  • 00852426007015 ()


  • CT system application software

VIDA|vision - 00852426007008

VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution

  • 00852426007008 ()


  • CT system application software
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