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No Description
Virtual Vision Health
2.6.0
In Commercial Distribution
- 00860010709733 ()
- Perimeter, automatic
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution
- 00862696000289 ()
- Laboratory instrument/analyser application software IVD
3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution
- 00860007402302 ()
- Radiation therapy software
No Description
Virtual Vision Health
3.2.0
In Commercial Distribution
- 00860010709795 ()
VV-021
- Perimeter, automatic
No Description
Virtual Vision Health
3.1.0
In Commercial Distribution
- 00860010709788 ()
- Perimeter, automatic
No Description
Virtual Vision Health
3.0.0
In Commercial Distribution
- 00860010709757 ()
- Perimeter, automatic
No Description
Virtual Vision Health
2.7.0
In Commercial Distribution
- 00860010709740 ()
- Perimeter, automatic
Software used by the clinician to interface with the WalkAide unit. This allows data collection,
analysis and parameter modification in order to correctly time the applied stimulation to the
user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution
- 00858184006130 ()
- Gait-enhancement electrical stimulation system, external
No Description
Synaptive Medical Inc
2.2
In Commercial Distribution
- 00670082000627 ()
SYN-0867
- Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
2.1
In Commercial Distribution
- 00670082000504 ()
SYN-0867
- Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.5
In Commercial Distribution
- 00670082000375 ()
SYN-0027
- Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.4
In Commercial Distribution
- 00670082000191 ()
SYN-0027
- Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.3
In Commercial Distribution
- 00670082000078 ()
SYN-0027
- Neurological stereotactic surgery system
The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution
- 06438147373901 ()
5020-1000
- Human genomic analysis interpretive software IVD
VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
ORTHO KINEMATICS, INC.
3
In Commercial Distribution
- 00868579000223 ()
- Radiological PACS software
No Description
ORTHO KINEMATICS, INC.
2.3
In Commercial Distribution
- 00868579000216 ()
- Radiological PACS software
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution
- 00865435000311 ()
SCIII SW
- Heater/cooler system tester kit
No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution
- 00856379007085 ()
- CAD/CAM software
Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution
- 00850921007196 ()
- General-purpose ultrasound imaging system
Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution
- 00850921007189 ()
- General-purpose ultrasound imaging system