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The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered.
The Final Fit software has two major functions:
1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000
2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.11US
In Commercial Distribution
- 04987669100035 ()
- Ophthalmic excimer laser system
No Description
Zoll Medical Corporation
1007-001050-01
In Commercial Distribution
- 00847946022204 ()
- Noninvasive device battery charger
No Description
Zoll Medical Corporation
1119-0500
In Commercial Distribution
- 00847946022174 ()
- Noninvasive device battery charger
SUREPOWER CHARGING STATION, REFURB
Zoll Medical Corporation
1119-0500-66
In Commercial Distribution
- 00847946019976 ()
- Noninvasive device battery charger
NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense.
NeviFile is used for printing reports as well as saving reports for viewing. NeviFile is also needed to be able to print reports from Nevisense via network,
immediately when an examination iscompleted and a report is created.
Scibase AB
142-0013
In Commercial Distribution
- 07350094440279 ()
142-0013
- Neoplasm electrical impedance spectrometer electrode array
The NeuroPace® Patient Data Management System (PDMS), part of the NeuroPace® RNS® System, is used to store and provide access to historical RNS® Neurostimulator and patient data. The PDMS can also be used to create and simulate detection settings that can be sent to a user identified NeuroPace® Programmer for use at a later date. PDMS is stand-alone software that is accessible via secure internet connection.
Neuropace, Inc.
Model 4340
In Commercial Distribution
- 00855547005007 ()
- Cannulated surgical drill bit, reusable
The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis.
INVIVOSCRIBE, INC.
850052003685
Not in Commercial Distribution
- 00850052003685 ()
K4120221
- Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology.
The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution
- 08437013457019 ()
1021720000
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-102
In Commercial Distribution
- 00855728005826 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-111
In Commercial Distribution
- 00855728005741 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system