vRad Viewer
Basic Information
- Brand Name
- vRad Viewer
- Primary DI
- 00862234000320
- Version / Model
- 1
- Company Name
- Virtual Radiologic Corporation
- Labeler DUNS
- 133841267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-13
- Public Version
- 2
- Public Version Date
- 2026-03-24
- Public Version Status
- Update
- Public Device Record Key
- 30783fdd-750f-4ed2-9420-cdfad3683a67
Device Description
The vRad Viewer software is used with general purpose computing hardware which meets or exceeds minimum specifications. The vRad Viewer is intended to receive, display, and transmit images for clinical purposes. The vRad Viewer is intended for installation on a PC meeting or exceeding minimum specifications and networked with storage components. The vRad Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad Viewer can process medical images from DICOM modalities, such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. The vRad Viewer may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and may only be used on monitors determined to be appropriate for the desired task.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862234000320 | GS1 |
Customer Contacts
- Phone
- 952-595-1100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241879 | 000 |