Non-Mydriatic Retinal Camera, Model TRC-NW8F
FDA 510(k) K100207 · Topcon Corp.
510(k) numberK100207
Submission
- Device name
- Non-Mydriatic Retinal Camera, Model TRC-NW8F
- Applicant
- Topcon Corp.
Tokyo, JP - Received
- January 25, 2010
- Decision date
- February 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
Other 510(k)s with product code HKI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253176 | TearViewHKI · Traditional | Beyond 700 Pty, Ltd. | 06/22/2026SE |
| K251353 | Eyer 2HKI · Traditional | Phelcom Technologies | 01/16/2026SE |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10)HKI · Traditional | Remidio Innovative Solutions Private Limited | 12/12/2025SE |
| K250770 | Optina-4C (MHRC-C1N)HKI · Traditional | Optina Diagnostics, Inc. | 09/04/2025SE |
| K243600 | 3nethra neo HD FA; 3nethra neo HDHKI · Traditional | Forus Health Pvt.Ltd | 08/14/2025SE |
| K250683 | Resolve Fundus CameraHKI · Traditional | Optain Health, Inc. | 04/30/2025SE |
| K243664 | Sentinel CameraHKI · Traditional | Ai Optics | 12/17/2024SE |
| K242508 | Verily Numetric Retinal CameraHKI · Traditional | Verily Life Sciences, LLC | 12/09/2024SE |
| K241049 | CANON Fundus Camera CR-10 (CR-10)HKI · Special | Canon, Inc. | 05/15/2024SE |
| K231230 | Optina-4C (MHRC-C1N)HKI · Special | Optina Diagnostics, Inc. | 12/05/2023SE |
More from Optina Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K171370 | IMAGEnet 6 Ophthalmic Data SystemNFJ · Traditional | 11/01/2017SE |
| K170164 | 3D OCT-1 MaestroOBO · Special | 03/03/2017SE |
| K161972 | Slit Lamp SL-D301HJO · Traditional | 12/09/2016SE |
Questions and answers
When was Non-Mydriatic Retinal Camera, Model TRC-NW8F cleared by the FDA?
Non-Mydriatic Retinal Camera, Model TRC-NW8F (K100207) received a 510(k) decision of Substantially Equivalent on February 12, 2010, 18 days after the submission was received.
What is the product code of K100207?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.