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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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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
TESSYS® Endoscopic Reamer
Joimax GmbH
TER352835
In Commercial Distribution

  • 04250337105138 ()
  • 04250337101215 ()

  • L350 mm / ID 2.8 mm / OD 3.5 mm
TER352835

  • Bone-resection orthopaedic reamer, single-use
joimax® Needle 21G, Pencil Point, graduated
Joimax GmbH
JMSN21G
In Commercial Distribution

  • 04250337103363 ()
  • 04250337100775 ()

  • L 200mm /OD 0.80mm /ID 0.50mm, silicone coated
JMSN21G

  • Hypodermic needle, single-use
joimax® Needle 18G, Quincke, graduated
Joimax GmbH
JMSN18G
In Commercial Distribution

  • 04250337103417 ()
  • 04250337100768 ()

  • L 150mm /OD 1.25mm /ID 1.0mm, silicone coated
JMSN18G

  • Hypodermic needle, single-use
Working Tube with handle, wide lip
Joimax GmbH
WTS127501
In Commercial Distribution

  • 04250337110293 ()

  • L124 mm / ID 6.5 mm / OD 7.5 mm
WTS127501

  • Endoscope sheath, reusable
joimax® Needle 18G, Quincke, graduated
Joimax GmbH
JMSN18G23
In Commercial Distribution

  • 04250337107996 ()
  • 04250337107989 ()

  • L 230mm /OD 1.25mm /ID 1.0mm, silicone coated
JMSN18G23

  • Hypodermic needle, single-use
joimax® Needle 18G, Quincke, graduated
Joimax GmbH
JMSN18XG
In Commercial Distribution

  • 04250337103400 ()
  • 04250337103394 ()

  • L 180mm /OD 1.25mm /ID 1.0mm, silicone coated
JMSN18XG

  • Hypodermic needle, single-use
joimax® Needle 18G, Quincke, graduated
Joimax GmbH
JMSN18G11
In Commercial Distribution

  • 04250337103387 ()
  • 04250337103370 ()

  • L 110mm /OD 1.25mm /ID 1.0mm, silicone coated
JMSN18G11

  • Hypodermic needle, single-use
joimax® Needle 21G, Pencil Point, graduated
Joimax GmbH
JMSN21XG
In Commercial Distribution

  • 04250337103356 ()
  • 04250337103349 ()

  • L 230mm /OD 0.8mm /ID 0.5mm, silicone coated
JMSN21XG

  • Hypodermic needle, single-use
iLESSYS® Pro Guiding Rod, conical
Joimax GmbH
GRD187350
In Commercial Distribution

  • 04250337115830 ()

  • L 180mm /ID 5.0mm /OD 7.3mm,longitudinally slotted
GRD187350

  • Endoscopic-access dilator, reusable
Guiding Rod, conical, longitudinal slanted
Joimax GmbH
GRD206520
In Commercial Distribution

  • 04250337113898 ()

  • L 200 / ID 4.2 mm / OD 7.8 mm
GRD206520

  • Endoscopic-access dilator, reusable
SAMPLE LINE,AGENT,MALE LUER,SPU,10',50/BX
SPACELABS HEALTHCARE (WASHINGTON), INC
NIBP Hoses and adapters
In Commercial Distribution

  • 00841522127369 ()
  • 10841522127366 ()

  • 1.19mm/0.047in ID, 305 cm/10 ft length
162-0046-01

  • Patient monitoring system module, multiple-gas
SAMPLE LINE,AGENT,W/SAMPLING TEE,10',50/BX
SPACELABS HEALTHCARE (WASHINGTON), INC
NIBP Hoses and adapters
In Commercial Distribution

  • 10841522127359 ()
  • 00841522127352 ()

  • 1.19mm/0.047in ID, 305 cm/10 ft length
015-0313-01

  • Patient monitoring system module, multiple-gas
Double Threaded Nylon Straight Connector
NATUS MEDICAL INCORPORATED
NT8501919
In Commercial Distribution


  • 1.1mm ID x 1.9mm OD (all dimensions nominal)
NT8501919

  • Cerebrospinal fluid shunt connector
Pudenz Three-Way Connector
NATUS MEDICAL INCORPORATED
NT8501908
In Commercial Distribution


  • 1.2mm ID x 2.4mm OD (all dimensions nominal)
NT8501908

  • Cerebrospinal fluid shunt connector
Lumbar-Peritoneal Shunt Stainless Steel Connector
NATUS MEDICAL INCORPORATED
NT75121S06
In Commercial Distribution


  • 0.635mm ID x 1.1938mm OD (all dimensions nominal)
NT75121S06

  • Cerebrospinal fluid shunt connector
Threaded Nylon Straight Connector
NATUS MEDICAL INCORPORATED
NT8501911
In Commercial Distribution


  • 1.1mm ID x 1.9mm OD (all dimensions nominal)
NT8501911

  • Cerebrospinal fluid shunt connector
Pudenz Right Angle Connector
NATUS MEDICAL INCORPORATED
NT8501902
In Commercial Distribution


  • 1.1mm ID x 1.9mm OD (all dimensions nominal)
NT8501902

  • Cerebrospinal fluid shunt connector
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