K182942 is an FDA 510(k) clearance for the Canon OCT-A1. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Canon, Inc. (Nakahara-Ku, Kawasaki, JP). The FDA issued a Cleared decision on July 24, 2019, 274 days after receiving the submission on October 23, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K182942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2018 |
| Decision Date | July 24, 2019 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO — Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |