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CompuFlo Epidural Computer Controlled Anesthesia System 220V
Milestone Scientific Inc.
EPI-6000-220
In Commercial Distribution
- 00618874116040 ()
- Electronic epidural space locator control unit
CompuFlo Epidural Computer Controlled Anesthesia System 110V
Milestone Scientific Inc.
EPI-6000-110
In Commercial Distribution
- 00618874116033 ()
- Electronic epidural space locator control unit
Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution
- 00812282020160 ()
903001-003
- Fully-implantable middle ear implant system
NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution
- 60889971067708 ()
1067701
- Computed radiography digital imaging scanner
NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution
- 60889971067685 ()
1067685
- Computed radiography digital imaging scanner
No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution
- 00860007954108 ()
- Cardiac mapping system computer
Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed.
Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.
APN HEALTH
Navik 3D v2.0
In Commercial Distribution
- 00869781000308 ()
200-00668
- Cardiac mapping system computer
No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution
- 00860007954177 ()
- Cardiac mapping system computer
No Description
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution
- 05415067023704 ()
H702370
- Cardiac catheterization laboratory computer
The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
Ablacon Inc.
AB-0007
In Commercial Distribution
- 00860457001568 ()
- Cardiac mapping system computer
Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution
- 03770019196038 ()
A002
- Cardiac mapping system computer
Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution
- 03770019196007 ()
A001
- Cardiac mapping system computer
Keyboard for Image Capture System
BR Surgical, LLC
BR900-1306
In Commercial Distribution
- 00840183528614 ()
BR900-1306
- Computer/medical device keyboard
DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution
- 10846835018585 ()
M665701SP
- Cardiac mapping system computer
EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution
- 10846835018578 ()
M660201SP
- Cardiac mapping system computer
EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution
- 10846835018554 ()
M660202SP
- Cardiac mapping system computer
External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution
- 10846835017885 ()
D160801
- Cardiac mapping system computer
Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007642
In Commercial Distribution
- 04056869010205 ()
- Cardiac catheterization laboratory computer
Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007641
In Commercial Distribution
- 04056869010199 ()
- Cardiac catheterization laboratory computer
No Description
Siemens Healthcare GmbH
10764562
In Commercial Distribution
- 04056869010144 ()
- Cardiac catheterization laboratory computer