FDA UDI
In Commercial Distribution
🇺🇸 United States
Discovery RF180
DI: 08054890480123
·
Model: OPERA D4000RF
·
GENERAL MEDICAL MERATE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Discovery RF180
- Primary DI
- 08054890480123
- Version / Model
- OPERA D4000RF
- Company Name
- GENERAL MEDICAL MERATE SPA
- Labeler DUNS
- 428658934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 5
- Public Version Date
- 2022-01-31
- Public Version Status
- Update
- Public Device Record Key
- 5ca800ea-e8f7-4b90-9ba3-763615e6624a
Device Description
It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37679 | Stationary general-purpose fluoroscopic x-ray system, digital | A stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08054890480123 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213081 | 000 |