Canon non-mydriatic retinal camera CR series
FDA 510(k) K201122 · Canon, Inc.
510(k) numberK201122
Submission
- Device name
- Canon non-mydriatic retinal camera CR series
- Applicant
- Canon, Inc.
Nakahara-Ku, Kawasaki, JP - Received
- April 27, 2020
- Decision date
- July 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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Questions and answers
When was Canon non-mydriatic retinal camera CR series cleared by the FDA?
Canon non-mydriatic retinal camera CR series (K201122) received a 510(k) decision of Substantially Equivalent on July 23, 2020, 87 days after the submission was received.
What is the product code of K201122?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.