Digital Retinal Camera
FDA 510(k) K123208 · Canon Inc. -Medical Equipment Group
510(k) numberK123208
Submission
- Device name
- Digital Retinal Camera
- Applicant
- Canon Inc. -Medical Equipment Group
Bunkyo-Ku, Tokyo, JP - Received
- October 12, 2012
- Decision date
- March 19, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Digital Retinal Camera cleared by the FDA?
Digital Retinal Camera (K123208) received a 510(k) decision of Substantially Equivalent on March 19, 2013, 158 days after the submission was received.
What is the product code of K123208?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.