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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R960 2024 Advent Calendar Contains: R061 Barnhart 5-6 R093 NEB 128-L5 Mini R138BC Montana Jack® (Breast Cancer Pink) R217 12 OAD Hawkeye R907 A. Battrell™ Quadrant Gracey Duo Pack T060 PingRing™--Sharpness Tester
PDT, INC.
R960 2024 Advent Calendar
In Commercial Distribution

  • 00813677025173 ()
R960

  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
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
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
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
202407
In Commercial Distribution

  • B359OAIIV2024071 ()
OAIIV202407

  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
R960 2024 Advent Calendar Rev 02 Contains: R061 Barnhart 5-6 R093 NEB 128-L5 Mini R138BC Montana Jack® (Breast Cancer Pink) R217 12 OAD Hawkeye R907 A. Battrell™ Quadrant Gracey Duo Pack T060 PingRing™--Sharpness Tester
PDT, INC.
R960 2024 Advent Calendar
In Commercial Distribution

  • 00813677025180 ()
R960

  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer
Kit Includes: (T009D-L) D-Series FlipTop™ Cassette - LiftOut Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R245) Cone Socket Mirror Handle (R375) Mixing Spatula-Applicator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium
PDT, INC.
R933 PDT Cement (Crown Seating) Kit
In Commercial Distribution

  • 00813677024947 ()
R933

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe
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