FDA.reportPublic FDA data

RAMSOFT, INC.

Matched from indexed company URL: Ramsoft Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96800283002807975RAMSOFT, INC.1N2026-01-01208-8 King St E TORONTO Ontario CA M5C 1B5
30101569833010156983RAMSOFT USA INC1Y2026-01-01131 Continental Drive Suite 301 Newark DE US 19713

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
461951473381246K222476OmegaAI Image ViewerLLZ2022-11-17
461951375821310K141881RAPIDRESULTSLLZ2014-10-31
461951535810719K052460POWERSERVER, POWERREADER, GATEWAY AND POWERCACHELLZ2005-09-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ32022-11-17

PMN#

GUDID#

RamSoft - RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.

Ramsoft Inc

2026-01-30

RamSoft - A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Ramsoft Inc

2026-01-30

Ramsoft - 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

2026-04-01

Ramsoft - 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

2026-01-19

RamSoft - 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

2025-10-24

RamSoft - 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

2025-08-11

RamSoft - 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

2025-05-12

RamSoft - 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

2024-11-06

RamSoft - RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.

Ramsoft Inc

2024-09-09

RamSoft - A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Ramsoft Inc

2024-09-09

RamSoft - 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

2024-09-06

RamSoft - 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

2024-07-30

RamSoft - PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer.PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data

Ramsoft Inc

2024-05-08

RamSoft - 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

2024-05-03

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