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SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution
- 00763000504526 ()
- Implantable cardiac device management application software
The EPIONE® RoboKit™ is used during the CT guided procedures performed with EPIONE®.
Sterile drapes are used to cover:
the robotic arm,
the touchscreen of the display cart,
the tray of the display cart supporting the mouse and the keyboard.
Reflective spheres to be placed on the tracked EPIONE instruments tracked.
QUANTUM SURGICAL
09-0057
In Commercial Distribution
- 03760305400260 ()
- Surgical optical-tracking spatial marker, single-use
The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®.
Sterile drapes are used to cover:
the robotic arm,
the touchscreen of the display cart,
the tray of the display cart supporting the mouse and the keyboard.
Reflective spheres to be placed on the tracked EPIONE instruments tracked.
The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
QUANTUM SURGICAL
09-0046
In Commercial Distribution
- 03760305400253 ()
- Surgical optical-tracking spatial marker, single-use
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures
QUANTUM SURGICAL
30-0001
In Commercial Distribution
- 03760305400086 ()
30-0001-01-USA
- Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing
reference points or anatomical landmarks in the medical images. It allows the verification
of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution
- 03760305400079 ()
02-0044
- Robotic surgical navigation system
The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution
- 03760305400062 ()
02-0027-19G
- Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification
of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0031
Not in Commercial Distribution
- 03760305400055 ()
02-0031
- Robotic surgical navigation system
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
QUANTUM SURGICAL
30-0001 v1.0.2
In Commercial Distribution
- 03760305400031 ()
- Robotic surgical navigation system
The Patient Reference is an instrument of the EPIONE device used to track the patient
position and motions including breathing.
QUANTUM SURGICAL
02-0026
In Commercial Distribution
- 03760305400024 ()
02-0026
- Robotic surgical navigation system
Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution
- 05060434420008 ()
51-000001-00
- Extracorporeal blood gas/pH monitor
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution
- 00860010168417 ()
- Endoscopic video image interpretive unit
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution
- 00860010168400 ()
- Endoscopic video image interpretive unit
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution
- 08055060110338 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution
- 08055060110321 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution
- 08055060110314 ()
- Endoscopic video image interpretive unit
Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution
- 10884521807259 ()
- Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution
- 10884521844544 ()
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution
- 10884521844537 ()
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
- Endoscopic video image interpretive unit
Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution
- 10884521821545 ()
- Endoscopic video image interpretive unit
AI Acutrak® Comp Screw Handle Assy
Acumed LLC
80-0097
In Commercial Distribution
- 10806378039850 ()
- Surgical instrument handle, non-torque-limiting
Visual Obturator with AI sheath scope lock
Avalign Technologies, Inc.
72-3130073
In Commercial Distribution
- 00190776209667 ()
- ENT examination/treatment system
FIBER OPTIC CABLE FOR RETRACTORS AI ADAPTOR
Avalign Technologies, Inc.
MFOC-10R
In Commercial Distribution
- 00190776189686 ()
- Electrical-only medical device connection cable, reusable
Fiberoptic Cable A AF Blue AI Cable
Avalign Technologies, Inc.
FTIMG166288BL
In Commercial Distribution
- 00190776189570 ()
- Electrical-only medical device connection cable, reusable
FIBER LIGHT CABLE w AI INSTRUMENT CONNECTORS
Avalign Technologies, Inc.
72-9819
In Commercial Distribution
- 00190776191177 ()
- Fibreoptic retractor handle
CAPNOSTAT Adult/Pediatric Ai rway Adapter, Reusable
Carefusion Finland 320 Oy
412341-001
Not in Commercial Distribution
- 10885403257001 ()
412341-001
- Carbon dioxide cuvette, reusable
Optiloc® Laboratory Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution
- 07630031759030 ()
3202.0002-OPT
- Dental precision attachment fitting/adjustment tool
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
- Retinal image analysis software
AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
Aeye Health, Inc.
AEYE-DS-Epic
Not in Commercial Distribution
- 00850035651018 ()
- Retinal image analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution
- 00850035651001 ()
- Retinal image analysis software
No Description
Digital Diagnostics Inc.
v2.3
In Commercial Distribution
- 00860005195626 ()
- Retinal image analysis software
No Description
Digital Diagnostics Inc.
V2
In Commercial Distribution
- 00860005195619 ()
- Retinal image analysis software
No Description
Eyenuk, Inc.
2.1.0
In Commercial Distribution
- 00860000470001 ()
- Retinal image analysis software
RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution
- 00732094223910 ()
411215
- Retinal image analysis software
No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution
- 00860475000383 ()
- Wound management image-analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
- Retinal image analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
- Retinal image analysis software
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution
- 07290017272504 ()
- 17290017272877 ()
- Wound management image-analysis software
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
MNT WND.EN.GN2
In Commercial Distribution
- 07290017272504 ()
- 17290017272716 ()
- Wound management image-analysis software
The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
MNT WND.EN.GEN
In Commercial Distribution
- 07290017272504 ()
- 17290017272709 ()
- Wound management image-analysis software
The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.G25
In Commercial Distribution
- 07290017272504 ()
- 17290017272556 ()
- Wound management image-analysis software