iCare ALTIUS CW
510(k) K234076
iCare ALTIUS CW is a medical device (FDA Class II; FDA product code NFJ, System, Image Management, Ophthalmic) made by Centervue S.P.A., cleared under FDA 510(k) K234076 on 22 Aug 2024, 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 | FDA 510(k)SESE | NumberK234076 | Date22 Aug 2024 | StatusActive |
Official records
- FDA 510(k) database K234076
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NFJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
From the manufacturer
Manufacturer's product page: iCare ALTIUS Cloud-based ophthalmic data management
Devices cleared under K234076
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| iCare ALTIUS CW | BACW000010 / iCare ALTIUS CW | 08053677040512 | — | On the market |
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