iCare ALTIUS CW
FDA 510(k) K234076 · Centervue S.P.A.
510(k) numberK234076
Submission
- Device name
- iCare ALTIUS CW
- Applicant
- Centervue S.P.A.
Padova, IT - Received
- December 21, 2023
- Decision date
- August 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260694 | Zeiss Clinic 360NFJ · Traditional | Carl Zeiss Meditec, AG | 07/17/2026SE |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave)NFJ · Traditional | Topcon Healthcare Solutions EMEA Oy | 06/04/2026SE |
| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | Topcon Corporation | 03/01/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | Carl Zeiss Meditec, AG | 12/21/2023SE |
| K232555 | HarmonyNFJ · Special | Topcon Healthcare Solutions | 11/20/2023SE |
| K231676 | CALLISTO eyeNFJ · Traditional | Carl Zeiss Meditec, AG | 08/28/2023SE |
| K232088 | Altris IMSNFJ · Traditional | Altris, Inc. | 07/31/2023SE |
| K220929 | ExcelsiorNFJ · Traditional | Merit Cro, Inc. | 10/31/2022SE |
| K213527 | ForumNFJ · Traditional | Carl Zeiss Meditec, AG | 08/15/2022SE |
| K211715 | RetinAI DiscoveryNFJ · Traditional | Retinai Medical AG | 04/28/2022SE |
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| K153181 | MaiaMYC · Traditional | 06/08/2016SE |
| K150320 | CompassMYC · Traditional | 06/30/2015SE |
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Questions and answers
When was iCare ALTIUS CW cleared by the FDA?
iCare ALTIUS CW (K234076) received a 510(k) decision of Substantially Equivalent on August 22, 2024, 245 days after the submission was received.
What is the product code of K234076?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.