RadiForce®
- Primary DI
- 04995047060666
- Company
- EIZO CORPORATION
- Model
- GX570
- Catalog number
- GX570-ARBK
- Device description
- 5MP Monochrome LCD Monitor
- Published
- 2025-09-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 691033005
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04995047060666 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 04995047060666 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| PGY | Display, Diagnostic Radiology | 2 | Radiology | 892.2050 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K252030 | 000 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | 2025-08-28 | PGY |
GMDN Terms
| Term | Definition |
|---|
| Image display unit, monochrome | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in only one colour. The device(s) that generates the visual data is not included with the display unit. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| 1-888-900-8383 | support@eizo.com |
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