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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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RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.7.7115
In Commercial Distribution

  • B359GWY6PRU70 ()
GWY6PRU7

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway 6
Ramsoft Inc
6.0.6.6015
In Commercial Distribution

  • B359GWY6PRU60 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway 6
Ramsoft Inc
6.0.5.5100
In Commercial Distribution

  • B359GWY6PRU510 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359GWY6PRU100 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution

  • B359GWY60 ()
GWY6

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway Router 6
Ramsoft Inc
6.0.9.9061
In Commercial Distribution

  • B359GWR6PRU9GA0 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway Router 6
Ramsoft Inc
6.0.9.9110
In Commercial Distribution

  • B359GWR6PRU91 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway Router 6
Ramsoft Inc
6.0.9.9060
In Commercial Distribution

  • B359GWR6PRU90 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway Router 6
Ramsoft Inc
6.0.8.8111
In Commercial Distribution

  • B359GWR6PRU80 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway Router 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359GWR6PRU720 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
Gateway Router 6
Ramsoft Inc
6.0.7.7115
In Commercial Distribution

  • B359GWR6PRU70 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway Router 6
Ramsoft Inc
6.0.6.6015
In Commercial Distribution

  • B359GWR6PRU60 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway Router 6
Ramsoft Inc
6.0.5.5100
In Commercial Distribution

  • B359GWR6PRU510 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway Router 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359GWR6PRU100 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway Router 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution

  • B359GWR60 ()
GWR6

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
The Enterprise Viewer is used for image distribution within the enterprise. It is used by clinicians as the primary user interface to view and interact with images. It is also used by Radiologists as a lightweight form to access images where they don’t have access to the complete diagnostic workstations. Enterprise Viewer is accessed through an HTML5 browser either over a desktop or using a capable mobile device.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107595 ()
839064

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
The Web Diagnostic Viewer is the radiologist diagnostic workstation including the clinical applications (implemented using Web technology) with similar functionality as the Desktop Diagnostic Viewer workstation.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107588 ()
839063

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
The Desktop Diagnostic Viewer is the end user’s primary user interface used to interact with clinical images. It includes the clinical applications.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107571 ()
839062

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107557 ()
839060

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
The Vue PACS (Web Diagnostic) viewer is an add-on capability that allows running the diagnostic viewer capabilities from a web browser.
Philips Medical Systems Nederland B.V.
Vue PACS (Web Diagnostic) - 12
In Commercial Distribution

  • 00884838103504 ()
8986010

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
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-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
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-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-839-55
In Commercial Distribution

  • J011602839550 ()
  • J011602839551 ()


  • Orthodontic palate expander screw, bonded
Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-838-55
In Commercial Distribution

  • J011602838550 ()
  • J011602838551 ()


  • Orthodontic palate expander screw, bonded
BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient’s skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.
Doseoptics LLC
BeamSite
In Commercial Distribution

  • 00860009184503 ()


  • Radiation therapy software
  • Radiation therapy system workstation, multi-purpose
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-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer
Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities.
CAPSOVISION, INC.
2
In Commercial Distribution

  • 00867770000223 ()
CLD

  • Video capsule endoscopy system application software
Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
ECHOPIXEL, INC.
EP-00003
In Commercial Distribution

  • 00851325007003 ()
SW-0001-1601

  • Radiology picture archiving and communication system workstation
  • Radiology DICOM image processing application software
Kit Includes: T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 R028 Amazing Gracey™ 13-14 R030 Amazing Gracey™ 15-16 R061 Barnhart 5-6 R135 204S R138 Montana Jack®
PDT, INC.
R974 Adult Prophy Kit
In Commercial Distribution

  • 00813677024428 ()
R974

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
No Description
MedicalCommunications GmbH
2023 (Build 2167)
In Commercial Distribution

  • 04260648620053 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
No Description
MedicalCommunications GmbH
2.6
In Commercial Distribution

  • 04260648620046 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
No Description
MedicalCommunications GmbH
Ashvins 2020
In Commercial Distribution

  • 04260648620008 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
  • Ophthalmology PACS software
No Description
Brainlab AG
15800
Not in Commercial Distribution

  • 04056481140977 ()


  • Medical image management system
  • Radiology picture archiving and communication system workstation
Kit Includes: T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 R096 N1 R139 N2 R138BC Montana Jack® (Breast Cancer Pink) R064 Columbia 13-14 R130S Jack B. Nimble® Slim Scaler
PDT, INC.
R977 Gingival Inflammation Kit
In Commercial Distribution

  • 00813677024527 ()
R977

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
OmegaAI Image Viewer is designed to view and manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Computed tomography, 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. OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack scroll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, cobb angle, probe, Mark ROI, and measurement. OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and presenting them in a zero-footprint, web user interface, allowing the users to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient.
Ramsoft Inc
2.0
In Commercial Distribution

  • B359OMEGAAIIV021 ()
OMEGAAIIV02

  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
The W-ADP software is an online platform to monitor Zeus V1 hand, monitor the usage of the device for the purpose of the settings and includes module to remotely connect with the patient.
AETHER BIOMEDICAL SP Z O O
W-ADP
In Commercial Distribution

  • 05904569152253 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R043 Amazing Gracey™ 13-14 Extended Reach R044 Amazing Gracey™ 15-16 Extended Reach R061 Barnhart 5-6 R089 Mini Me™ R120 Montana 4-5™ R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R169 11-12 ODU Extended Reach Explorer R216 ACE™-12 Short Probe R245 Cone Socket Mirror Handle T042 Meriam Tweezers T050 #5 Mirror (15/16")
PDT, INC.
R916 PDT SRP Kit
In Commercial Distribution

  • 00813677024855 ()
R916

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, 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
202505
In Commercial Distribution

  • B359OAIIV2025051 ()
OAIIV202505

  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
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