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MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution
- 00860006066307 ()
- Ultrasound imaging system application software
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
810-00012
In Commercial Distribution
- 00860004541745 ()
- Wearable multiple vital physiological parameter monitor
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution
- 00860008932204 ()
- Wearable multiple vital physiological parameter monitoring system
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution.
STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution
- 00866463000465 ()
REF 200008
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
1.1
Not in Commercial Distribution
- 00866463000410 ()
- MRI system application software
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution
- 06938396423018 ()
- Portable basic diagnostic x-ray system, digital
No Description
EMPATICA SRL
Care Portal
In Commercial Distribution
- 00853858006263 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution
- 00853858006256 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution
- 00853858006249 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
EmbracePlus
In Commercial Distribution
- 00853858006232 ()
EMBP-CC-MS
- Multiple vital physiological parameter monitoring system, home-use
No Description
Sira Medical, Inc.
1
In Commercial Distribution
- G67910 ()
- Surgical planning/navigation-enhancement system
VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution
- 18800124900014 ()
- 08800124900017 ()
- Portable basic diagnostic x-ray system, digital
CARESCAPE CENTRAL STATION V1 UPGRADE KIT FROM CIC V5 ON MP100
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1 upgrade
Not in Commercial Distribution
- 00840682109833 ()
- Centralized patient monitor
ASSY CSCS V1 MP100D DESKTOP
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1
Not in Commercial Distribution
- 00840682109826 ()
- Centralized patient monitor
CARESCAPE CENTRAL STATION V2 MAI 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Integrated MAI 700
Not in Commercial Distribution
- 00840682109666 ()
- Centralized patient monitor
CARESCAPE CENTRAL STATION V2 MAS 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Standard MAS 700
Not in Commercial Distribution
- 00840682109604 ()
- Centralized patient monitor
No Description
GE Vingmed Ultrasound AS
Plug-in v201
In Commercial Distribution
- 00840682104333 ()
- Ultrasound imaging system application software
NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution
- 10846835011678 ()
FG170000
- Cardiac mapping system
CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution
- 10846835000870 ()
FG-5400-00
- Cardiac mapping system
No Description
GE MEDICAL SYSTEMS, INC.
XR200amx
In Commercial Distribution
- 00840682115278 ()
- Portable basic diagnostic x-ray system, digital
No Description
GE Healthcare Finland Oy
Web Viewer
In Commercial Distribution
- 00840682106498 ()
- Centralized patient monitor
No Description
GE Vingmed Ultrasound AS
Software Only v201
In Commercial Distribution
- 00840682103961 ()
- Ultrasound imaging system application software
No Description
GE HEALTHCARE
UNIVERSAL VIEWER 6.0
In Commercial Distribution
- 00840682103800 ()
- Medical image management system
V100 GENERIC ATO MODEL
Ge Medical Systems Information Technologies, Inc.
V100
In Commercial Distribution
- 00840682103091 ()
- Multiple vital physiological parameter monitoring system, clinical
No Description
GE HEALTHCARE
UNIVERSAL VIEWER ZFP CLIENT 6.0
In Commercial Distribution
- 00840682102988 ()
- Medical image management system
MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution
- 00840682124591 ()
- MRI system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v202
In Commercial Distribution
- 00840682123518 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v202
In Commercial Distribution
- 00840682123501 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v113
In Commercial Distribution
- 00840682121095 ()
- Ultrasound imaging system application software
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
1.0
In Commercial Distribution
- 00840682119306 ()
- SPECT system application software
No Description
Innokas Yhtymä Oy
VC150
In Commercial Distribution
- 00840682117722 ()
- Multiple vital physiological parameter monitoring system, clinical
Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution
- 00840682147101 ()
- Ultrasound imaging system application software
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution
- 00840682147071 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v204
In Commercial Distribution
- 00840682146883 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v204
In Commercial Distribution
- 00840682146876 ()
- Ultrasound imaging system application software
No Description
GE HEALTHCARE
UNIVERSAL VIEWER 7.0
In Commercial Distribution
- 00840682145794 ()
- Medical image management system
V100 GENERIC ATO MODEL No CE
Ge Medical Systems Information Technologies, Inc.
V100
Not in Commercial Distribution
- 00840682144292 ()
- Multiple vital physiological parameter monitoring system, clinical
No Description
GE Vingmed Ultrasound AS
Software Only v203
In Commercial Distribution
- 00840682141703 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v203
In Commercial Distribution
- 00840682141697 ()
- Ultrasound imaging system application software
QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
In Commercial Distribution
- 10841522131462 ()
91389
- Multiple vital physiological parameter monitoring system, clinical
DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution
- 10841522131141 ()
- 21.5"
011-0262-00
- Centralized patient monitor
DISPLAY,21.5",CAPACITIVE TOUCH,BLACK, ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution
- 10841522129780 ()
011-0241-02
- Centralized patient monitor
No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution
- 08800017100159 ()
- Nitrogen plasma skin surface treatment system
No Description
VISIOMED GROUP
BW-HR1
In Commercial Distribution
- 03760165449270 ()
- Cardiac mapping system
Bolt Navigation Case
Circinus Medical Technology LLC
BN002-02
In Commercial Distribution
- BN981BN002023 ()
BN002-02
- Surgical planning/navigation-enhancement system
Bolt Navigation Unit, Gen 2.0
Circinus Medical Technology LLC
BN001-02
In Commercial Distribution
- BN981BN001021 ()
BN001-02
- Surgical planning/navigation-enhancement system
Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution
- B981BN00201101 ()
- B981BN00201103 ()
BN002-01-10
- Surgical planning/navigation-enhancement system
Bolt Navigation Unit
Circinus Medical Technology LLC
BN001-01-01
In Commercial Distribution
- B981BN0010101 ()
BN001-01-01
- Surgical planning/navigation-enhancement system
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution
- 03760415600000 ()
- Ultrasound imaging system application software