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Software, Version 1.0, iDMS™ Data Management System
The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
ACCURAY INCORPORATED
1049889
In Commercial Distribution
- M65810498890 ()
NA
- Linear accelerator system
Software, Version 2.0, iDMS Data Management System
The iDMS Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
ACCURAY INCORPORATED
1061513
In Commercial Distribution
- M65810615130 ()
NA
- Patient health record information system application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution
- J00714000520521 ()
1400052
- Surgical power tool system control unit, line-powered
- Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution
- J00714000510511 ()
1400051
- Surgical power tool system control unit, line-powered
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCR-ADAA00000
In Commercial Distribution
- B769ICRADAA00000 ()
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCP-ADAAA0000
In Commercial Distribution
- B769ICPADAAA0000 ()
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci.
ICUBATE, INC
iCC-AAJA00000
In Commercial Distribution
- B769ICCAAJA00000 ()
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.
ICUBATE, INC
iCC-AAQA00000
In Commercial Distribution
- B769ICCAAQA00000 ()
- Multiple bloodstream bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
PROC iBOND Universal Kit 1x2ML
Heraeus Kulzer GmbH
66098280
In Commercial Distribution
- J014660982800 ()
66098280
- Dentine bonding agent/set
iBond Universal Sample Kit
Heraeus Kulzer GmbH
66088898
In Commercial Distribution
- J014660888980 ()
66088898
- Dentine bonding agent/set