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The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.
Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
v2.7 Global
In Commercial Distribution
- 04250903202520 ()
2092504-270
- Electrocardiographic ambulatory recorder
The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.
Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
v2.6 Global
In Commercial Distribution
- 04250903202469 ()
2092504-260
- Electrocardiographic ambulatory recorder
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.
Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operators
under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
Global SP04
In Commercial Distribution
- 04250903202445 ()
2092504-254
- Electrocardiographic ambulatory recorder
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.
Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operators
under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
Global
In Commercial Distribution
- 04250903200144 ()
2092504-001
- Electrocardiographic ambulatory recorder
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution
- 00843152104000 ()
SW-1
- Electromagnetic surgical navigation device tracking system
IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
Centerline Biomedical, Inc.
T02111
In Commercial Distribution
- 10843152103024 ()
- 00843152103027 ()
T02111
- Electromagnetic surgical navigation device tracking system
IOPS™ Tracking Pad 1
Centerline Biomedical, Inc.
TP-1
In Commercial Distribution
- 10843152103000 ()
- 00843152103003 ()
TP-1
- Electromagnetic surgical navigation device tracking system
Guidewire Handle
Centerline Biomedical, Inc.
H01035
In Commercial Distribution
- 10843152102058 ()
- 00843152102051 ()
H01035
- Electromagnetic surgical navigation device tracking system
Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
Centerline Biomedical, Inc.
ATW-2
In Commercial Distribution
- 10843152102034 ()
- 00843152102037 ()
ATW-2
- Cardiac/peripheral vascular guidewire, single-use
IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
Centerline Biomedical, Inc.
SSH-1
In Commercial Distribution
- 10843152102010 ()
- 00843152102013 ()
SSH-1
- Cardiac/peripheral vascular guidewire, single-use