RamSoft
Basic Information
- Brand Name
- RamSoft
- Primary DI
- B359OMEGAAIIV021
- Version / Model
- 2.0
- Catalog Number
- OMEGAAIIV02
- Company Name
- Ramsoft Inc
- Labeler DUNS
- 255320228
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-02
- Public Version
- 1
- Public Version Date
- 2023-10-10
- Public Version Status
- New
- Public Device Record Key
- 14cb814a-def4-439e-901d-d0043a00f755
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44087 | Radiology information system application software | An application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, 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 work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network. | No | Active |
| 40943 | Radiology picture archiving and communication system workstation | A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B359OMEGAAIIV021 | HIBCC |