Clearance Summary
DIGITAL RETINAL CAMERA received FDA 510(k) clearance under submission number K102013, sponsored by Canon Inc. -Medical Equipment Group. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-10-29.
- Submission: K102013
- Applicant / Sponsor: Canon Inc. -Medical Equipment Group
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2010-10-29
Classification & Regulation
This clearance is catalogued under FDA product code HKI and 21 CFR 886.1120, within the Ophthalmic review panel as a Class II device.