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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
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution
- 00858290006598 ()
- Dental unfilled resin sealant/coating
No Description
NINEPOINT MEDICAL, INC.
94301-MI
In Commercial Distribution
- 00859591006249 ()
94301-MI
- Endoscopic optical coherence tomography system
and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
12 Fr
In Commercial Distribution
- 10860000931356 ()
- 00860000931359 ()
- Catheter Gauge: 12 French
- 12 FR (4.2mm)X 52”(130cm)
GFTB 512
- Nasogastric feeding tube
and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
10 Fr
In Commercial Distribution
- 10860000931349 ()
- 00860000931342 ()
- 10 Fr (3.7mm)X 49”(100cm)
- Catheter Gauge: 10 French
GFTB 510
- Nasogastric feeding tube
and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution
- 10860000931332 ()
- 00860000931335 ()
- Catheter Gauge: 8 French
- 8 FR (3.3mm)X 32”(80cm)
GFTB 508
- Nasogastric feeding tube
No Description
Biomet Orthopedics, LLC
909874
In Commercial Distribution
- 00880304863422 ()
- 4.5 MM
909874
- Ligament bone anchor
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
045-003428-00
In Commercial Distribution
- 06936415904081 ()
- General-purpose multi-parameter bedside monitor
No Description
Biomet Orthopedics, LLC
110026848
In Commercial Distribution
- 00880304812949 ()
- 2.9 mm
110026848
- Tendon/ligament bone anchor, non-bioabsorbable