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The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1040
Not in Commercial Distribution
- 05694110063045 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1030
Not in Commercial Distribution
- 05694110063038 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1010
Not in Commercial Distribution
- 05694110063021 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1022
Not in Commercial Distribution
- 05694110063014 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1020
Not in Commercial Distribution
- 05694110063007 ()
- Electroencephalograph
- Electroencephalographic monitoring system
STarFix™ Designer DBS
FHC, INC.
C0265-01-00922
In Commercial Distribution
- 00873263009222 ()
C0265-01
- Stereotactic neuronavigation/planning system
STarFix™ Designer Laptop, 1x
FHC, INC.
C0267-00917
In Commercial Distribution
- 00873263009178 ()
C0267
- Stereotactic neuronavigation/planning system
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution
- 04260521363619 ()
- Dental milling system, CAD/CAM, chairside
- CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.2
In Commercial Distribution
- 04260521363534 ()
- Dental milling system, CAD/CAM, chairside
- CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution
- 04260521363527 ()
- Dental milling system, CAD/CAM, chairside
- CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles
and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental
laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid
abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer
of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.0
In Commercial Distribution
- 04260521363510 ()
- CAD/CAM software
- Dental milling system, CAD/CAM, chairside
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
TRIBUN HEALTH
6.1.0 IVDUS
In Commercial Distribution
- 03760408001005 ()
- Pathology information system
Ai-Rad Companion Organs RT About Box
Siemens Healthcare GmbH
11545290
In Commercial Distribution
- 04056869274645 ()
- Radiology DICOM image processing application software
- Radiological PACS software
No Description
Siemens Healthcare GmbH
11665508
In Commercial Distribution
- 04056869973371 ()
- Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
11665278
Not in Commercial Distribution
- 04056869955667 ()
- Radiology DICOM image processing application software
MD Auto Segmentation for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 00195278560384 ()
5919805
- CT system application software
LibreViewGov
ABBOTT DIABETES CARE INC
72157-01
In Commercial Distribution
- 00357599826000 ()
72157-01
- Self-care monitoring/reporting software
LibreView
ABBOTT DIABETES CARE INC
72156-01
In Commercial Distribution
- 00357599823009 ()
72156-01
- Self-care monitoring/reporting software
No Description
Siemens Healthcare GmbH
11823875
In Commercial Distribution
- 04068151010404 ()
- Radiology DICOM image processing application software
BASE UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-123A
In Commercial Distribution
- 00841983102592 ()
QI-123A
- Electroencephalograph
EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-124A
In Commercial Distribution
- 00841983101199 ()
QI-124A
- Electroencephalograph
Electrode junction box (256 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution
- 00841983100659 ()
JE-120A-24
- Electroencephalograph
Electrode junction box (192 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-23
In Commercial Distribution
- 00841983100642 ()
JE-120A-23
- Electroencephalograph
Electrode junction box (128 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-22
In Commercial Distribution
- 00841983100635 ()
JE-120A-22
- Electroencephalograph
Electrode junction box (64 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A
In Commercial Distribution
- 00841983100628 ()
JE-120A-21
- Electroencephalograph
ASC Legacy™ 5.7mm-Compatible Titanium Blank
Preat Corporation
9008565
In Commercial Distribution
- 00842092183229 ()
9008565
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible WP Titanium Blank
Preat Corporation
9000665
In Commercial Distribution
- 00842092182871 ()
9000665
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible RP Titanium Blank
Preat Corporation
9000565
In Commercial Distribution
- 00842092182864 ()
9000565
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible NP Titanium Blank
Preat Corporation
9000465
In Commercial Distribution
- 00842092182857 ()
9000465
- Dental implant suprastructure, permanent, preformed
ASC Zimmer TSV 5.7mm-Compatible Titanium Blank
Preat Corporation
9000365
In Commercial Distribution
- 00842092182840 ()
9000365
- Dental implant suprastructure, permanent, preformed