Clearance Summary
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI received FDA 510(k) clearance under submission number K031629, sponsored by Canon USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-06-06.
- Submission: K031629
- Applicant / Sponsor: Canon USA, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2003-06-06
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.