FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ResolutionMD® Web
DI: B037RESMDWEB0
·
Model: RMD-WEB-I
·
ResolutionMD Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ResolutionMD® Web
- Primary DI
- B037RESMDWEB0
- Version / Model
- RMD-WEB-I
- Company Name
- ResolutionMD Inc.
- Labeler DUNS
- 243325225
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-17
- Public Version
- 7
- Public Version Date
- 2024-10-04
- Public Version Status
- Update
- Public Device Record Key
- e51cf4d2-289d-4146-8348-aa0a6721a86f
- Distribution End Date
- 2022-12-31
Device Description
ResolutionMD® Web is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
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
- No
- 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 |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B037RESMDWEB0 | HIBCC |