# Optovue, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 16 (2006–2022): 16 510(k) clearances
- Product codes: OBO (7), HLI (7), HKI (2)
- Predicates its devices cite: 26 (20 its own); citations of its devices by later devices: 34 (20 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carl Zeiss Meditec, AG: 2 (https://510kreport.com/company/carl-zeiss-meditec)
- Bioptigen, Inc.: 1 (https://510kreport.com/company/bioptigen)
- Oculus Optikgerate GmbH: 1 (https://510kreport.com/company/oculus-optikgerate)
- Centervue S.P.A.: 1 (https://510kreport.com/company/centervue)
- Carl Zeiss Ophthalmic Systems, Inc.: 1 (https://510kreport.com/company/carl-zeiss-ophthalmic-systems)

## Firms that cite its devices most
- Nidek, Inc.: 3 (https://510kreport.com/company/nidek)
- Optos Plc.: 2 (https://510kreport.com/company/optos)
- Heidelberg Engineering GmbH: 2 (https://510kreport.com/company/heidelberg-engineering)
- Oculus Optikgerate GmbH: 1 (https://510kreport.com/company/oculus-optikgerate)
- Topcon Corporation: 1 (https://510kreport.com/company/topcon)
- Canon, Inc.: 1 (https://510kreport.com/company/canon)
- Tomey Corporation: 1 (https://510kreport.com/company/tomey)
- Chongqing Bio Newvision Medical Equipment, Ltd.: 1 (https://510kreport.com/company/chongqing-bio-newvision-medical-equipment)

## Its most-cited devices
- K121739: Ivue with Normative Database (2013), cited by 6
- K071250: CA, Model: Cam (2007), cited by 5
- K122572: Icam Fundus Camera (2013), cited by 4
- K101505: Rtvue Model Rtvue 100 (2010), cited by 4
- K180660: Avanti (2018), cited by 3
- K062552: RTVUE (2006), cited by 3

## Recent decisions
- K222166: SOLIX (Nov 9, 2022)
- K180660: Avanti (Jun 8, 2018)
- K163475: iVue (Jun 9, 2017)
- K153080: RTVue XR OCT Avanti with AngioVue Software (Feb 11, 2016)
- K133892: IVUE 500 (Mar 19, 2014)
- K130656: Ifusion (Jul 3, 2013)
- K121739: Ivue with Normative Database (Jan 18, 2013)
- K122572: Icam Fundus Camera (Jan 11, 2013)

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