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PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer.
PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution
- B359PSPACS0 ()
PSPACS6
- Radiology information system
- Radiology information system application software
- Radiology picture archiving and communication system workstation
- Radiological PACS software
The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements.
Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation.
Each Kit contains:
1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material.
1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water.
1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride.
5 plastic 1 ml syringes
2 non-activated test cuvettes (blue with clear caps, stir bars, and probes)
SIENCO, INC.
900-1318
In Commercial Distribution
- B55890013181 ()
900-1318
- Multiple coagulation factor IVD, control
The Ampa One System is a computerized, electromechanical medical device that produces and delivers
non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the
cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L
Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target
the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major
Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from
prior antidepressant medication in the current episode.
Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural
tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are
generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor
charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil.
A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces
a current in conducting materials e.g. the body tissue. If the current induced in the human body is of
sufficient amplitude and duration, it will excite neurons.
Neuromodulatory Devices & Applications LLC
AMPA-001
In Commercial Distribution
- 00860011991205 ()
- Magnetic neural stimulation system
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit).
Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037)
The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms. There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
-
In Commercial Distribution
- 17290018151027 ()
- Endoscopic electromechanical surgical system
- Electrical mains power cable
Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]).
Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each.
The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
The Nerivio Infinity package under this UDI contains 1 refill unit.
Theranica Bio-Electronics Ltd.
FGD000100
In Commercial Distribution
- 07290017578118 ()
FGD000100
- Craniofacial analgesia electrical stimulator
Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]).
Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each.
The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
The Nerivio Infinity package under this UDI contains 3 refill units.
Theranica Bio-Electronics Ltd.
FGD000100
In Commercial Distribution
- 07290017578101 ()
FGD000100
- Craniofacial analgesia electrical stimulator
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point.
The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit).
The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms.
There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
10
In Commercial Distribution
- 07290018151013 ()
- 17290018151010 ()
FP-03-0003
- Endoscopic electromechanical surgical system
The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased array
receive only coil used for obtaining diagnostic images of the shoulder in Magnetic
Resonance Imaging Systems. Compared to predicate devices, the submitted
device offers easier patient setup and greater SNR due to its compatibility with
3.OT MRI scanners.
The submitted device consists of semi-flexible foam covered housing, consisting
of eight antennas. The antennas are uniquely positioned with the appropriate
overlap to cancel out mutual coupling effects from adjacent antennas or
decoupled from an adjacent antenna using a transformer. Pre-amplifier
decoupling reduces any remaining decoupling between the antennas.
The coil is held in place over the imaging area via a cross body strap. A system
interface cable connects to the coil at the top of the housing. The flexible foam
covered housing along with the body strap enable the proper positioning on the
patient before laying down and holds the coil in place while scanning is being
performed.
To ensure safety, each antenna is equipped with active and passive transmit
decoupling circuits. Active decoupling is achieved via diodes that receive signals
from the scanner to turn the coil to a high impedance state during system RF
transmit. Crossed diodes are installed on each antenna acting as passive
switches. These passive switches provide additional safety in case the active
circuitry does not receive signal from the scanner.
NEOCOIL, LLC
05
In Commercial Distribution
- 00856181003053 ()
- MRI system coil, radio-frequency
OmegaAI Image Viewer is designed to access, process, manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Nuclear medicine, MRI, Ultrasound, laboratory systems, and images from other sources such as handheld devices and cameras, endoscopy or other sources of images and videos. It can perform various image manipulation activities and store the modifications as presentation state along with the original study for future reference. The OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack roll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, cobb angle, probe, Mark ROI, and measurement. The OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and presenting them in a web user interface, allowing the user to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient. Available on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, the OmegaAI Image Viewer provides access to medical images in a convenient way for health care professionals to use as a diagnostic viewer and for review purposes. OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android.
Ramsoft Inc
202505
In Commercial Distribution
- B359OAIIV2025051 ()
OAIIV202505
- Radiology information system application software
- Radiology picture archiving and communication system workstation
- Radiological PACS software
OmegaAI Image Viewer is designed to access, process, manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Nuclear medicine, MRI, Ultrasound, laboratory systems, and images from other sources such as handheld devices and cameras, endoscopy or other sources of images and videos. It can perform various image manipulation activities and store the modifications as presentation state along with the original study for future reference.
The OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack roll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, cobb angle, probe, Mark ROI, and measurement.
The OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and presenting them in a web user interface, allowing the user to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient.
Available on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, the OmegaAI Image Viewer provides access to medical images in a convenient way for health care professionals to use as a diagnostic viewer and for review purposes.
OmegaAI Image Viewer supports major desktop and mobile browsers such as Microsoft Edge, Chrome, Safari, Apple iOS, Android.
Ramsoft Inc
3.0
In Commercial Distribution
- B359OAIIVV31 ()
OMEGAAIIV03
- Radiology information system application software
- Radiology picture archiving and communication system workstation
- Radiological PACS software