The following data is part of a premarket notification filed by Canon Inc. -medical Equipment Group with the FDA for Ophthalmic Software Platform Rx.
| Device ID | K173689 |
| 510k Number | K173689 |
| Device Name: | Ophthalmic Software Platform RX |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Canon Inc. -Medical Equipment Group 9-1, Imaikami-cho, Nakahara-ku, Kawasaki, JP 211-8501 |
| Contact | Shinji Mori |
| Correspondent | Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-01 |
| Decision Date | 2018-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292084696 | K173689 | 000 |