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Mobile Keyboard Dock with backpack and battery. Includes Power Cable Holder
Bk Medical ApS
UA1214
Not in Commercial Distribution
- 05704916001056 ()
- General-purpose ultrasound imaging system
Precision Systems OSMETTE III osmometer with Barcode Reader
Precision Systems, Inc.
5010B
In Commercial Distribution
- 00850041049830 ()
5010B
- Osmometric analyser IVD
Precision Systems OSMETTE XL with Barcode Reader
Precision Systems, Inc.
5007B
In Commercial Distribution
- 00850041049762 ()
5007B
- Osmometric analyser IVD
Siliclone X-Act with 4 Tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution
- 00850047788009 ()
10112
- Earmould impression material
Seamfree Single Syringe with Tips
Vista Dental
1
In Commercial Distribution
- 00850194007336 ()
104-01
- Dental restorative unfilled resin kit, standard
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution
- 00858290006598 ()
- Dental unfilled resin sealant/coating
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
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution
- 00852184003458 ()
- Percutaneous electrical stimulation lead external pulse generator cable, reusable
Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
ACESSA HEALTH INC.
7700
In Commercial Distribution
- 00854763006188 ()
- Surgical ultrasound imaging transducer