Icam Fundus Camera
FDA 510(k) K122572 · Optovue, Inc.
510(k) numberK122572
Submission
- Device name
- Icam Fundus Camera
- Applicant
- Optovue, Inc.
Fremont, CA, US - Received
- August 23, 2012
- Decision date
- January 11, 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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| K121739 | Ivue with Normative DatabaseHLI · Traditional | 01/18/2013SE |
| K120238 | Rtvue XR OctHLI · Special | 04/03/2012SE |
| K111505 | Rtvue Cam with Corneal Power UpgradeOBO · Traditional | 09/08/2011SE |
| K103266 | IstandHLI · Traditional | 06/03/2011SE |
Questions and answers
When was Icam Fundus Camera cleared by the FDA?
Icam Fundus Camera (K122572) received a 510(k) decision of Substantially Equivalent on January 11, 2013, 141 days after the submission was received.
What is the product code of K122572?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.