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No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution
- 05060634690010 ()
- Ultrasound imaging system application software
- Cardiac mapping system application software
RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421088
In Commercial Distribution
- 05414734210881 ()
H421088
- Electrical-only medical device connection cable, reusable
- Cardiac mapping system
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.
The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.
In particular, the device is intended to provide:
Linear distance measurements of anatomical structures,
Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,
Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies,
Measurement of brightness ratio between structures and in particular between the liver and the kidney,
Estimates of speed of sound in the liver.
The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution
- 03770023859011 ()
- Ultrasound imaging system application software
- Hepatic ultrasound elastography system
EVA SELECT DIRECT SIZE 2 SENSOR ONLY
ImageWorks
9992413205
In Commercial Distribution
- D83399924132050 ()
9992413205
- General-purpose dental x-ray system application software
- Dental digital imaging sensor, intraoral
EVA SELECT DIRECT SIZE 1 SENSOR ONLY
ImageWorks
9992413105
In Commercial Distribution
- D83399924131050 ()
9992413105
- General-purpose dental x-ray system application software
- Dental digital imaging sensor, intraoral
EVA SELECT SIZE 2 SYSTEM
ImageWorks
9992412200
In Commercial Distribution
- D83399924122000 ()
9992412200
- General-purpose dental x-ray system application software
- Dental digital imaging sensor, intraoral
EVA SELECT SIZE 1 SYSTEM
ImageWorks
9992412100
In Commercial Distribution
- D83399924121000 ()
9992412100
- Dental digital imaging sensor, intraoral
- General-purpose dental x-ray system application software
EVA SELECT DIRECT SIZE 2 SYSTEM
ImageWorks
9992413200
In Commercial Distribution
- D83399924132000 ()
9992413200
- General-purpose dental x-ray system application software
- Dental digital imaging sensor, intraoral
EVA SELECT DIRECT SIZE 1 SYSTEM
ImageWorks
9992413100
In Commercial Distribution
- D83399924131000 ()
9992413100
- General-purpose dental x-ray system application software
- Dental digital imaging sensor, intraoral
Coil 400 Standard, 15mm x 45cm
PENUMBRA, INC.
4002C1545-A
In Commercial Distribution
- 00815948025103 ()
4002C1545
- Neurovascular embolization coil
- Surgical microscope video camera, sterilizable
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution
- B3945000001120 ()
500-0001-12
- Multiple vital physiological parameter monitoring system, clinical
- Multiple-patient intensive/general healthcare physiologic monitoring system
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution
- B3945000001010 ()
500-0001-01
- Multiple-patient intensive/general healthcare physiologic monitoring system
- Multiple vital physiological parameter monitoring system, clinical
Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
BIONESS INC.
BITS-3055
In Commercial Distribution
- 00815962020610 ()
- Perceptual-coordination assistive training device
HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001
Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware
ACIST MEDICAL SYSTEMS, INC.
016323
Not in Commercial Distribution
- 40841716102057 ()
- Cardiovascular ultrasound imaging system
E-Scribe ECG Data Management Workstation - Rx system, floating; English system language; 220V power; Tower workstation computer hardware (no keyboard, mouse, or display); 19 in. display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution
- 00732094264999 ()
ESWKST-FAB-AAXXX
- Patient health record information system application software
Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution
- 00857534006684 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution
- 00857534006677 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution
- 00857534006660 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution
- 00857534006653 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
IMRIS Imaging, Inc.
Application Platform 4.0 KIT
In Commercial Distribution
- 00857534006646 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution
- 00857534006639 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution
- 00857534006622 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution
- 00857534006493 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution
- 00857534006363 ()
- Operating room audiovisual data/device management system application software
- Operating room audiovisual data/device management system
No Description
Brainlab AG
15800
Not in Commercial Distribution
- 04056481140977 ()
- Medical image management system
- Radiology picture archiving and communication system workstation
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution
- B201CGOHM0 ()
- B201CGOHM1 ()
CG-OH-M
- Radiological video camera patient positioning/tracking system camera
- Optical surgical navigation device tracking system
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution
- B201CGOH1 ()
- B201CGOH0 ()
CG-OH
- Radiological video camera patient positioning/tracking system camera
- Optical surgical navigation device tracking system
BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution
- 00817421021442 ()
- 00817421021435 ()
- 00817421022739 ()
P010308
- Surgical planning/navigation-enhancement system
- Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution
- 00817421021428 ()
- 00817421021411 ()
- 00817421022722 ()
P010307
- Surgical planning/navigation-enhancement system
- Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 4mm
XNAV TECHNOLOGIES LLC
P010306
In Commercial Distribution
- 00817421021404 ()
- 00817421021398 ()
- 00817421022715 ()
P010306
- Surgical planning/navigation-enhancement system
- Craniofacial bone screw, non-bioabsorbable