IMAGEnet 6 Ophthalmic Data System
FDA 510(k) K171370 · Topcon Corporation
510(k) numberK171370
Submission
- Device name
- IMAGEnet 6 Ophthalmic Data System
- Applicant
- Topcon Corporation
Tokyo, JP - Received
- May 10, 2017
- Decision date
- November 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NFJ
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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 |
| K234076 | iCare ALTIUS CWNFJ · Traditional | Centervue S.P.A. | 08/22/2024SE |
| 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 |
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| 510(k) | Device | Decision |
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| K253039 | Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional | 11/07/2025SE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional | 07/17/2024SE |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))OBO · Traditional | 04/10/2024SE |
| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | 03/01/2024SE |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)OBO · Traditional | 10/30/2023SE |
| K221111 | Non-Mydriatic Retinal Camera NW500HKI · Traditional | 08/29/2022SE |
| K173119 | DRI OCT TritonOBO · Traditional | 01/19/2018SE |
| K170164 | 3D OCT-1 MaestroOBO · Special | 03/03/2017SE |
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Questions and answers
When was IMAGEnet 6 Ophthalmic Data System cleared by the FDA?
IMAGEnet 6 Ophthalmic Data System (K171370) received a 510(k) decision of Substantially Equivalent on November 1, 2017, 175 days after the submission was received.
What is the product code of K171370?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.