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Magnetic Resonance Diagnostic Device
FUJIFILM CORPORATION
APERTO Lucent
In Commercial Distribution
- 04573596200704 ()
APERTO Lucent
- Full-body MRI system, permanent magnet
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)
which assists qualified healthcare professionals to identify anatomy in live ultrasound images.
The Anatomy PNB receives scan images in real-time from a compatible general-purpose
ultrasound machine. It then processes the images using deep learning artificial intelligence
algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The
original view from the ultrasound machine is not affected and is always available both on the
ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution
- 05060878810052 ()
- Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)
which assists qualified healthcare professionals to identify anatomy in live ultrasound images.
The Anatomy PNB receives scan images in real-time from a compatible general-purpose
ultrasound machine. It then processes the images using deep learning artificial intelligence
algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The
original view from the ultrasound machine is not affected and is always available both on the
ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution
- 05060878810021 ()
- Ultrasound imaging system application software
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance
Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.
Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution
- 05060508110002 ()
- Angiographic x-ray system application software
Inliant System, US, Full Package
Navigate Surgical Technologies Inc
900010-1
In Commercial Distribution
- 00850049386111 ()
9000101
- Surgical planning/navigation-enhancement system
Consumable - Fiducial Kit
Navigate Surgical Technologies Inc
900007-0
In Commercial Distribution
- 00850049386029 ()
9000070
- Surgical planning/navigation-enhancement system
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00850038861711 ()
- Multiple vital physiological parameter monitoring system, home-use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00850038861322 ()
- Multiple vital physiological parameter monitoring system, home-use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00850038861292 ()
- Multiple vital physiological parameter monitoring system, home-use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s
pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and
provides a notification to the caregiver, prompting them to assess the infant. The Dream
Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in
these measured values, and their relationship to the preset ranges, over time. These PR and
SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1
to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00850038861230 ()
- Multiple vital physiological parameter monitoring system, home-use
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00850038861056 ()
- Multiple vital physiological parameter monitoring system, home-use
AcQMap to DiamondTemp Generator Adapter Cable
ACUTUS MEDICAL, INC.
800818
Not in Commercial Distribution
- 00850027837635 ()
800818
- Cardiac mapping system
The ClinicalAccess®, Pro Connect is a feature rich medical station designed to enhance efficiency and patient care in healthcare settings. The Pro Connect comes equipped with dual 22" monitors, ClearCam® PTZ with 12x optical zoom, Jabra conferencing microphone and speaker, integrated small form factor PC, and lockable device storage.
Globalmed Holdings, LLC
1.0
In Commercial Distribution
- 00850033167221 ()
1CAP001-C01 / 1CAP001-C02
- Medical image management system
Videoconferencing cart
Globalmed Holdings, LLC
First Exam Station
In Commercial Distribution
- 00850033167139 ()
- Medical image management system
Compact Desktop Telemedicine Station with Ergonomic User and Storage Features
Globalmed Holdings, LLC
1LES001
In Commercial Distribution
- 00850033167092 ()
1LES001
- Medical image management system
Telemedicine Station with Ergonomic User and Storage Features
Globalmed Holdings, LLC
GMR12150000
In Commercial Distribution
- 00850033167085 ()
GMR12150000
- Medical image management system
Wall Mounted Telemedicine Station with Ergonomic User and Storage Features.
Globalmed Holdings, LLC
1WDC003
In Commercial Distribution
- 00850033167078 ()
1WDC003
- Medical image management system
Mobile Telemedicine Station with Ergonomic User and Storage Features.
Globalmed Holdings, LLC
1CAS004
In Commercial Distribution
- 00850033167061 ()
1CAS004
- Medical image management system
Transportable Compact Mobile Telemedicine Station with Ergonomic User and Storage Features.
Globalmed Holdings, LLC
1TES006
In Commercial Distribution
- 00850033167054 ()
1TES006
- Medical image management system
Compact Mobile Telemedicine Station with Ergonomic User and Storage Features
Globalmed Holdings, LLC
1CSL001
In Commercial Distribution
- 00850033167016 ()
1CSL001
- Medical image management system