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Adaptive electronics control unit.
Comoveit
Smart ECU
In Commercial Distribution
- 05430002911007 ()
- Wheelchair steering/control unit
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution
- 15430002734023 ()
- 05430002734026 ()
- Instrument/analyser specimen/reagent container carrier IVD
Feops HEARTguide Simulation Application
FEops
3.1.0
In Commercial Distribution
- 05430002070094 ()
05430002070094
- Radiology DICOM image processing application software
FEops HEARTguide ALPACA
FEops
3.1.0
In Commercial Distribution
- 05430002070087 ()
05430002070087
- Radiology DICOM image processing application software
FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
The version v1.4.2 supports next to the WATCHMAN device also the WATCHMAN FLX and the AMULET devices
FEops
1.4.2
Not in Commercial Distribution
- 05430002070070 ()
- Radiology DICOM image processing application software
FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution
- 05430002070063 ()
- Radiology DICOM image processing application software
FEops HEARTguide Simulation Application
FEops
3.0.0
Not in Commercial Distribution
- 05430002070056 ()
05430002070056
- Radiology DICOM image processing application software
FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ is prescription use only.
FEops
1.4.1
Not in Commercial Distribution
- 05430002070032 ()
- Radiology DICOM image processing application software
Sunrise sensor 2 (single night)
Sunrise
2
In Commercial Distribution
- 05430001896091 ()
A600
- Home-use sleep apnoea recording system
Sunrise sensor 2 (multi-nights)
Sunrise
2
In Commercial Distribution
- 05430001896084 ()
A500
- Home-use sleep apnoea recording system