Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Use for yes and no responses Choose between two options of food, drink, or activities Provide a way to make two unique requests like "I need help" and "I'm done" Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000045
In Commercial Distribution

  • 00850011150108 ()
10000045

  • Assistive speech generator
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Provide a unique response to a question like "What is the weather like outside?" Respond to an assessment Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty" Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution

  • 00186648000531 ()
10000028

  • Assistive speech generator
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
Move into multi-message communication with the BIG Step-by-Step speech device. Activate the large colored top to play the first message. When done, activate the top again to play another message. New sequences of messages are easily and quickly recorded to the BIG Step-by-Step on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Record pages of a book to tell a story Count from 1 to 10 Ask a series of questions Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIG Step-by-Step. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000043
In Commercial Distribution

  • 00850011150085 ()
10000043

  • Assistive speech generator
Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the LITTLEmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000042
In Commercial Distribution

  • 00850011150078 ()
10000042

  • Assistive speech generator
Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000041
In Commercial Distribution

  • 00850011150061 ()
10000041

  • Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay
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