Iris X80
Iris X80 (IRIS-X80) is a Class I device made by Digital Doc LLC, cleared under FDA 510(k) K981663 on 10 Aug 1998 and listed in FDA GUDID since 21 Jan 2025 (UDI-DI 00813557020144), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813557020144 | Date21 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981663 | Date10 Aug 1998 | StatusActive |
Official records
- AccessGUDID record 00813557020144
- FDA 510(k) database K981663
Across registries
- FDA 510(k) K981663 decided 10 Aug 1998 Active
- FDA GUDID UDI-DI 00813557020144 listed 21 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K981663
- Listed FDA GUDID 00813557020144
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Iris
- Generic name
- Intraoral camera
- Model / Ref / Catalog
- X80, IRIS-X80
- Primary DI / UDI-DI
- 00813557020144
- 510(k) Number
- FDA product code
- EIA
- GMDN term
- Intraoral camera
- Device class
- Class I
- Regulation number
- 872.6640
- GUDID distribution status
- In Commercial Distribution
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