Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for
FDA 510(k) K082364 · Topcon Corp.
510(k) numberK082364
Submission
- Device name
- Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for
- Applicant
- Topcon Corp.
Cincinnati, OH, US - Received
- August 18, 2008
- Decision date
- September 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
More from Carl Zeiss Meditec, AG
| 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 Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for cleared by the FDA?
Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for (K082364) received a 510(k) decision of Substantially Equivalent on September 30, 2008, 43 days after the submission was received.
What is the product code of K082364?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.