Clearance Summary
Ophthalmic Software Platform RX received FDA 510(k) clearance under submission number K173689, sponsored by Canon Inc. -Medical Equipment Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-02-23.
- Submission: K173689
- Applicant / Sponsor: Canon Inc. -Medical Equipment Group
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2018-02-23
Classification & Regulation
This clearance is catalogued under FDA product code NFJ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.