The following data is part of a premarket notification filed by Canon, Inc.-medical Equipment Group with the FDA for Digital Retinal Camera.
| Device ID | K123208 |
| 510k Number | K123208 |
| Device Name: | DIGITAL RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANON, INC.-MEDICAL EQUIPMENT GROUP 4-1-17 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Contact | Izumi Maruo |
| Correspondent | Izumi Maruo CANON, INC.-MEDICAL EQUIPMENT GROUP 4-1-17 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2013-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292074338 | K123208 | 000 |