VISIUSeye 117533-000
VISIUSeye 117533-000 is a Class I device made by IMRIS Imaging, Inc., listed in FDA GUDID since 4 Oct 2024 (UDI-DI 00857534006295), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857534006295 | Date4 Oct 2024 | StatusListed |
Official records
- AccessGUDID record 00857534006295
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- VISIUSeye
- Generic name
- Freestanding headrest, reusable
- Model / reference
- 117533-000
- Primary DI / UDI-DI
- 00857534006295
- FDA product code
- FTY
- GMDN term
- Freestanding headrest, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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