# Topcon Medical Systems, Inc.

- Location (FDA's records): North Reading, MA
- FDA decisions: 11 (2003–2018): 11 510(k) clearances
- Product codes: NFJ (5), OBO (2), HKI (2), HKO (1), HJO (1)
- Predicates its devices cite: 16 (4 its own); citations of its devices by later devices: 20 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Topcon Corporation: 6 (https://510kreport.com/company/topcon)
- Haag-Streit AG: 2 (https://510kreport.com/company/haag-streit)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Canon Components, Inc.: 1 (https://510kreport.com/company/canon-components)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Digital Healthcare, Ltd.: 1 (https://510kreport.com/company/digital-healthcare)

## Firms that cite its devices most
- Topcon Corporation: 8 (https://510kreport.com/company/topcon)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Topcon Healthcare Solutions: 1 (https://510kreport.com/company/topcon-healthcare-solutions)
- Canon Inc. -Medical Equipment Group: 1 (https://510kreport.com/company/canon-medical-equipment-group)
- Optos Plc.: 1 (https://510kreport.com/company/optos)
- Eyekor, LLC: 1 (https://510kreport.com/company/eyekor)
- Takagi Seiko Co., Ltd.: 1 (https://510kreport.com/company/takagi-seiko)
- Topcon Healthcare Solutions EMEA Oy: 1 (https://510kreport.com/company/topcon-healthcare-solutions-emea)

## Its most-cited devices
- K093313: Synergy (2009), cited by 4
- K151952: Synergy ODM (2015), cited by 2
- K182376: Harmony (2018), cited by 2
- K072971: Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness (2009), cited by 2
- K110489: Slit Lamp SL-2G (2011), cited by 2
- K123101: TRC-50DX Retinal Camera (2013), cited by 2

## Recent decisions
- K182376: Harmony (Sep 28, 2018)
- K151952: Synergy ODM (Oct 1, 2015)
- K132438: Imagenet 5 PC Software System (Oct 17, 2013)
- K132667: Synergy Odm (Oct 9, 2013)
- K123101: TRC-50DX Retinal Camera (Jun 5, 2013)
- K123460: TRC-NW300 Non-Mydriatic Retinal Camera (Feb 6, 2013)
- K110489: Slit Lamp SL-2G (May 23, 2011)
- K093313: Synergy (Dec 2, 2009)

Source page: https://510kreport.com/company/topcon-medical-systems