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The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005878 ()
DSC014-03-US
- Basic diagnostic x-ray system application software
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
- 00858012005861 ()
D4D0192
- Basic diagnostic x-ray system application software
No Description
Avive Solutions, Inc.
AED01
In Commercial Distribution
- 00860002508559 ()
- Rechargeable public automated external defibrillator
No Description
Medicomp
MC-4425
In Commercial Distribution
- 10858409005600 ()
- 00858409005603 ()
MC-4425
- Straight/elbow breathing circuit connector, single-use
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution
- 00858290006598 ()
- Dental unfilled resin sealant/coating
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00150
Not in Commercial Distribution
- 00873263001509 ()
FC1008
- Neurosurgical micro targeting drive
microTargeting Controller with motor option for use with STar and mT Drives
FHC, INC.
FC1008-00144
Not in Commercial Distribution
- 00873263001448 ()
FC1008
- Neurosurgical micro targeting drive
microTargeting Controller with encoder option for use with STar and mT Drives
FHC, INC.
FC1007-00143
In Commercial Distribution
- 00873263001431 ()
FC1007
- Neurosurgical micro targeting drive
The MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.
Mirion Technologies (capintec), Inc.
240-110
In Commercial Distribution
- 00879942070767 ()
240-110
- MRI system table, non-powered
Hemorrhage Occluder Pin Large - 14 mm head
SURGIN SURGICAL INSTRUMENTATION, INC.
CR1014
In Commercial Distribution
- 00868742000111 ()
- 10868742000118 ()
- Width: 14 Millimeter
CR1014
- Haemorrhage control pin