Digital Retinal Camera, CR-1 Mark II
FDA 510(k) K090466 · Canon, Inc.
510(k) numberK090466
Submission
- Device name
- Digital Retinal Camera, CR-1 Mark II
- Applicant
- Canon, Inc.
Lake Success, NY, US - Received
- February 21, 2009
- Decision date
- March 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Digital Retinal Camera, CR-1 Mark II cleared by the FDA?
Digital Retinal Camera, CR-1 Mark II (K090466) received a 510(k) decision of Substantially Equivalent on March 23, 2009, 30 days after the submission was received.
What is the product code of K090466?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.