The following data is part of a premarket notification filed by Canon Inc. with the FDA for Canon Oct-a1.
| Device ID | K182942 |
| 510k Number | K182942 |
| Device Name: | Canon OCT-A1 |
| Classification | Tomography, Optical Coherence |
| Applicant | Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, JP 211-08501 |
| Contact | Tatsuya Yamazaki |
| Correspondent | Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-23 |
| Decision Date | 2019-07-24 |
| Summary: | summary |