iRay Cetus 50R01
by iRay Imaging Technology (Haining) Limited
iRay Cetus 50R01 is a diagnostic x-ray system generator (FDA Class I; FDA product code IZO, Generator, High-Voltage, X-Ray, Diagnostic) made by iRay Imaging Technology (Haining) Limited, listed in FDA GUDID since 31 Oct 2022 (UDI-DI 06975501940046), registry data as of 23 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 | Number06975501940046 | Date31 Oct 2022 | StatusListed |
Official records
- AccessGUDID record 06975501940046
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- iRay
- Generic name
- Diagnostic x-ray system generator, stationary
- Model / reference
- Cetus 50R01
- Primary DI / UDI-DI
- 06975501940046
- FDA product code
- IZO
- GMDN term
- Diagnostic x-ray system generator, stationary
- Device class
- Class I
- Regulation number
- 892.1700
- GUDID distribution status
- In Commercial Distribution
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