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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
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
202411
In Commercial Distribution
- B359OAIIV2024111 ()
OAIIV202411
- 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
202408
In Commercial Distribution
- B359OAIIV2024081 ()
OAIIV202408
- 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
202407
In Commercial Distribution
- B359OAIIV2024071 ()
OAIIV202407
- Radiology information system application software
- Radiology picture archiving and communication system workstation
- Radiological PACS software
The LifeWarmer Quantum Battery is an extremely powerful and intelligent battery in a small, lightweight package- weighing only 16 oz. The Quantum Battery powers the whole warming system with state-of-the-art Lithium Polymer cells harnessing 44 Volts of electrical potential. The battery, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4°F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min.
The Quantum Battery is built for use in the most austere and tactical environments. It is IP67 rated for water resistance and is the only portable fluid warming battery that has a disable feature on the audible alarm for tactical considerations. The Quantum Life Warmer Battery is rechargeable with a service life of 500 charge/discharge cycles.
It is important to keep the Quantum Battery charged and ready for use. Always re-charge after deployment, even if the battery was not fully discharged. The battery can be kept plugged into the Quantum Charger, as the intelligent Battery senses charge demand and will charge as needed but never overcharge. The Battery has a “Status” button to check the state of charge at any moment, with 3 colored LEDs to inform the user about the condition of the battery.
NORTH AMERICAN RESCUE, LLC
63-5902
In Commercial Distribution
- 00868058000423 ()
35-0001
- Conduction blood/fluid warmer
The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.
The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.
Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.
Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
MERIDIAN BIOSCIENCE, INC.
480750
In Commercial Distribution
- 00840733102226 ()
480750
- Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)
The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a rescue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)
It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.
The i-PAD NFI200 is capable of saving data and transmitting them to an external device.
Indications for Use
The i-PAD NFI200 is used to treat a person suffering from sudden cardiac arrest
(SCA) and who exhibits symptoms of
· No movement and no response when shaken
· No normal breathing
Contraindication for Use
The device must not be used on a person who:
* Is moving or is responsive when shaken
* Is breathing normally
Target Patients
* Adults
* Children over 55 lbs or 8 years old
* The device is not to be used on children below 8 years old or under 55 lbs
Intended User
The device is intended for use by persons:
* who have been specifically trained in its operation
* who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized emergency medical response program in accordance with local and state requirements
CU Medical Systems, Inc.
NF1200
In Commercial Distribution
- 08809435480003 ()
- Non-rechargeable public semi-automated external defibrillator
DEVICE DESCRIPTION
The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system
PACKAGING CONTENTS
A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion.
INDICATIONS FOR USE
The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination
DIRECTIONS FOR USE
Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field
Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use
Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure
CONTRAINDICATIONS
The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques
WARNINGS
Contents supplied sterile. Do not use if sterile barrier is damaged
Do not use the GreenEgg™ if the device has been opened or damaged
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician
STORAGE
Store at room temp, avoid extreme temps
DISPOSAL
Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices
REUSE PRECAUTION STATEMENT
For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.
Endoglow, LLC
EP1000-30
In Commercial Distribution
- 00860001161618 ()
- 10860001161615 ()
- Length: 12.5 Inch
- Outer Diameter: 30 Millimeter
EP1000-30
- Colonic bougie
INTENDED USE/ CONTRAINDICATIONS
PremierPro™ Air Transfer Mats are indicated for patients:
Who are unable to transfer or turn by their own effort, both assisted and unassisted.
Whose size and weight present possible risks to caregivers involved in the transfer of the patient.
PRECAUTIONS & WARNINGS
Use two or more caregivers during patient transfers.
Do not use transfer mat until user manual is reviewed.
Do not leave patient unattended on inflated transfer mat.
Do not attempt to move patient on uninflated transfer mat.
The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg).
AIR SUPPLY
Air supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3711
In Commercial Distribution
- 10818566019216 ()
- 00818566019219 ()
- Length: 39 Inch
3711
- Patient transfer system, powered