Canon 60 Zoom Fundus Camera CF-60ZA Ophthalmic Cam
FDA 510(k) K844898 · Canon USA, Inc.
510(k) numberK844898
Submission
- Device name
- Canon 60 Zoom Fundus Camera CF-60ZA Ophthalmic Cam
- Applicant
- Canon USA, Inc.
Lake Success, NY, US - Received
- December 17, 1984
- Decision date
- January 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
Other 510(k)s with product code HKI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253176 | TearViewHKI · Traditional | Beyond 700 Pty, Ltd. | 06/22/2026SE |
| K251353 | Eyer 2HKI · Traditional | Phelcom Technologies | 01/16/2026SE |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10)HKI · Traditional | Remidio Innovative Solutions Private Limited | 12/12/2025SE |
| K250770 | Optina-4C (MHRC-C1N)HKI · Traditional | Optina Diagnostics, Inc. | 09/04/2025SE |
| K243600 | 3nethra neo HD FA; 3nethra neo HDHKI · Traditional | Forus Health Pvt.Ltd | 08/14/2025SE |
| K250683 | Resolve Fundus CameraHKI · Traditional | Optain Health, Inc. | 04/30/2025SE |
| K243664 | Sentinel CameraHKI · Traditional | Ai Optics | 12/17/2024SE |
| K242508 | Verily Numetric Retinal CameraHKI · Traditional | Verily Life Sciences, LLC | 12/09/2024SE |
| K241049 | CANON Fundus Camera CR-10 (CR-10)HKI · Special | Canon, Inc. | 05/15/2024SE |
| K231230 | Optina-4C (MHRC-C1N)HKI · Special | Optina Diagnostics, Inc. | 12/05/2023SE |
More from Optina Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090623 | Digital Radiography CXDI-40G CompactMQB · Traditional | 03/24/2009SE |
| K033624 | Pacs Software Solution 2003LLZ · Special | 12/15/2003SE |
| K031633 | Canon Inc., Digital Radiography, Model CXDI-40CMQB · Traditional | 06/11/2003SE |
| K031629 | Canon Non-Mydriatic Retinal Camera, Model Cr-DgiHKI · Traditional | 06/06/2003SE |
| K023750 | Cannon Digital Radiography Model CXDI-40GMQB · Traditional | 11/22/2002SE |
| K023586 | Dr-Er Verfsion of Canon X-Ray Digital CamerasMQB · Special | 11/05/2002SE |
| K003689 | Canon X-Ray Digital Camera, Model CXDI-31IXK · Traditional | 01/02/2002SE |
| K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100HLI · Traditional | 06/21/2000SE |
| K992547 | Canon X-Ray Digital Camera, Model CXDI-22MQB · Traditional | 10/13/1999SE |
| K981556 | Canon X-Ray Digital Camera CXDI-11MQB · Traditional | 11/04/1998SE |
Questions and answers
When was Canon 60 Zoom Fundus Camera CF-60ZA Ophthalmic Cam cleared by the FDA?
Canon 60 Zoom Fundus Camera CF-60ZA Ophthalmic Cam (K844898) received a 510(k) decision of Substantially Equivalent on January 22, 1985, 36 days after the submission was received.
What is the product code of K844898?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.