K201273 is an FDA 510(k) clearance for the ImageSPECTRUM. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Canon, Inc. (Nakahara-Ku, Kawasaki, JP). The FDA issued a Cleared decision on September 25, 2020, 136 days after receiving the submission on May 12, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K201273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2020 |
| Decision Date | September 25, 2020 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NFJ — System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |