CALLISTO eye
FDA 510(k) K232944 · Carl Zeiss Meditec, AG
510(k) numberK232944
Submission
- Device name
- CALLISTO eye
- Applicant
- Carl Zeiss Meditec, AG
Dublin, CA, US - Received
- September 20, 2023
- Decision date
- December 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K234076 | iCare ALTIUS CWNFJ · Traditional | Centervue S.P.A. | 08/22/2024SE |
| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | Topcon Corporation | 03/01/2024SE |
| 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 |
More from Retinai Medical AG
| 510(k) | Device | Decision |
|---|---|---|
| K260694 | Zeiss Clinic 360NFJ · Traditional | 07/17/2026SE |
| K243878 | Clarus (700)QER · Traditional | 04/17/2025SE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…JAD · Traditional | 01/10/2025SE |
| K233911 | VISULAS combiHQF · Traditional | 09/06/2024SE |
| K240215 | Blue 400; Blue 400 SQFX · Traditional | 06/28/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | 05/17/2024SE |
| K233421 | Rescan 700OBO · Traditional | 03/08/2024SE |
| K232051 | VISULAS greenHQF · Traditional | 10/24/2023SE |
| K230350 | VISULAS yagHQF · Traditional | 09/22/2023SE |
| K232159 | QEVO SystemGWG · Special | 09/21/2023SE |
Questions and answers
When was CALLISTO eye cleared by the FDA?
CALLISTO eye (K232944) received a 510(k) decision of Substantially Equivalent on December 21, 2023, 92 days after the submission was received.
What is the product code of K232944?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.