The following data is part of a premarket notification filed by Canon Inc. with the FDA for Imagespectrum.
| Device ID | K201273 |
| 510k Number | K201273 |
| Device Name: | ImageSPECTRUM |
| Classification | Device, Storage, Images, Ophthalmic |
| Applicant | Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, JP 211-8501 |
| Contact | Akira Hirai |
| Correspondent | Ryan Bouchard Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, JP 211-8501 |
| Product Code | NFF |
| Subsequent Product Code | HKI |
| Subsequent Product Code | NFG |
| Subsequent Product Code | NFJ |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-12 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292182729 | K201273 | 000 |