# Topcon Corporation

- Location (FDA's records): Tokyo, JP
- FDA decisions: 23 (2004–2026): 23 510(k) clearances
- Names in FDA's records: Topcon Corporation (14); Topcon Corp. (9)
- Product codes: OBO (8), HKI (7), NFJ (3), HJO (3), NQE (1), HKX (1)
- 510(k) review time since 2016: median 128 days, against 157 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 39 (18 its own); citations of its devices by later devices: 34 (18 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Topcon Medical Systems, Inc.: 8 (https://510kreport.com/company/topcon-medical-systems)
- Canon USA, Inc.: 3 (https://510kreport.com/company/canon-usa)
- Kowa Co., Ltd.: 2 (https://510kreport.com/company/kowa)
- Nidek, Inc.: 2 (https://510kreport.com/company/nidek)
- Konan Medical, Inc.: 1 (https://510kreport.com/company/konan-medical)
- Haag-Streit AG: 1 (https://510kreport.com/company/haag-streit)
- Crystalvue Medical Corporation: 1 (https://510kreport.com/company/crystalvue-medical)
- Optovue, Inc.: 1 (https://510kreport.com/company/optovue)

## Firms that cite its devices most
- Topcon Medical Systems, Inc.: 6 (https://510kreport.com/company/topcon-medical-systems)
- Carl Zeiss Meditec, AG: 2 (https://510kreport.com/company/carl-zeiss-meditec)
- Eyeic Corporation: 1 (https://510kreport.com/company/eyeic)
- Diagnos, Inc.: 1 (https://510kreport.com/company/diagnos)
- Ophthalmic Imaging Systems: 1 (https://510kreport.com/company/ophthalmic-imaging-systems)
- Haag-Streit AG: 1 (https://510kreport.com/company/haag-streit)
- Truevision Systems, Incorporated: 1 (https://510kreport.com/company/truevision-systems)
- Medivision Medical Imaging, Ltd.: 1 (https://510kreport.com/company/medivision-medical-imaging)

## Its most-cited devices
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for (2008), cited by 6
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera (2004), cited by 5
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F (2010), cited by 4
- K161509: 3D OCT-1 Maestro (2016), cited by 3
- K133667: Slit Lamp SL-D701 (2014), cited by 2
- K090115: Retina Camera TRC-NW7SF Mark II (2009), cited by 2

## Recent decisions
- K262637: SLIT LAMP SL-D4 (Type: LED) (Sep 18, 2026)
- K253039: Auto Kerato-Refracto Tonometer TRK-3 Omnia (Nov 7, 2025)
- K241081: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (Jul 17, 2024)
- K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (Apr 10, 2024)
- K232828: IMAGEnet6 Ophthalmic Data System (Mar 1, 2024)
- K231222: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (Oct 30, 2023)
- K221111: Non-Mydriatic Retinal Camera NW500 (Aug 29, 2022)
- K173119: DRI OCT Triton (Jan 19, 2018)

Source page: https://510kreport.com/company/topcon