Digital Retinal Camera
FDA 510(k) K102013 · Canon Inc. -Medical Equipment Group
510(k) numberK102013
Submission
- Device name
- Digital Retinal Camera
- Applicant
- Canon Inc. -Medical Equipment Group
Tachikawa-Shi, Tokyo, JP - Received
- July 16, 2010
- Decision date
- October 29, 2010
- 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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| K111682 | Digital RadiographyMQB · Special | 09/02/2011SE |
| K103591 | Digital RadiographyMQB · Special | 03/29/2011SE |
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Questions and answers
When was Digital Retinal Camera cleared by the FDA?
Digital Retinal Camera (K102013) received a 510(k) decision of Substantially Equivalent on October 29, 2010, 105 days after the submission was received.
What is the product code of K102013?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.