# Canon USA, Inc.

- Location (FDA's records): Lake Success, NY
- FDA decisions: 48 (1984–2009): 48 510(k) clearances
- Product codes: HKI (12), MQB (6), KPX (5), HKO (4), HLI (2), JAA (2), IYO (2), HLQ (2), HJI (1), HKX (1), HLM (1), HKN (1)
- Predicates its devices cite: 12 (9 its own); citations of its devices by later devices: 35 (9 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
- Canon, Inc.: 1 (https://510kreport.com/company/canon)
- Astro Office Products, Inc.: 1 (https://510kreport.com/company/astro-office-products)
- Heidelberg Engineering GmbH: 1 (https://510kreport.com/company/heidelberg-engineering)

## Firms that cite its devices most
- Canon, Inc.: 8 (https://510kreport.com/company/canon)
- Topcon Corporation: 3 (https://510kreport.com/company/topcon)
- Trex Enterprises Corp.: 2 (https://510kreport.com/company/trex-enterprises)
- Canon Inc. -Medical Equipment Group: 2 (https://510kreport.com/company/canon-medical-equipment-group)
- Sedecal., Sa.: 2 (https://510kreport.com/company/sedecal)
- Optical Imaging, Ltd.: 1 (https://510kreport.com/company/optical-imaging)
- Kowa Co., Ltd.: 1 (https://510kreport.com/company/kowa)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)

## Its most-cited devices
- K981556: Canon X-Ray Digital Camera Cxdi-11 (1998), cited by 7
- K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM (1998), cited by 5
- K031633: Canon Inc., Digital Radiography, Model Cxdi-40C (2003), cited by 4
- K023750: Cannon Digital Radiography Model Cxdi-40G (2002), cited by 4
- K003689: Canon X-Ray Digital Camera, Model Cxdi-31 (2002), cited by 3
- K992547: Canon X-Ray Digital Camera, Model Cxdi-22 (1999), cited by 3

## Recent decisions
- K090623: Digital Radiography Cxdi-40G Compact (Mar 24, 2009)
- K033624: Pacs Software Solution 2003 (Dec 15, 2003)
- K031633: Canon Inc., Digital Radiography, Model Cxdi-40C (Jun 11, 2003)
- K031629: Canon Non-Mydriatic Retinal Camera, Model CR-Dgi (Jun 6, 2003)
- K023750: Cannon Digital Radiography Model Cxdi-40G (Nov 22, 2002)
- K023586: DR-ER Verfsion of Canon X-Ray Digital Cameras (Nov 5, 2002)
- K003689: Canon X-Ray Digital Camera, Model Cxdi-31 (Jan 2, 2002)
- K992606: Canon Laser Blood Flowmeter (CLBF) Model 100 (Jun 21, 2000)

Source page: https://510kreport.com/company/canon-usa