510(k) K173689
K173689 is an FDA 510(k) premarket notification submitted by Canon Inc. -Medical Equipment Group for the device "Ophthalmic Software Platform RX". The FDA issued a decision of Substantially Equivalent on February 23, 2018. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Canon Inc. -Medical Equipment Group has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2018
- Date Received
- December 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type