K233561 is an FDA 510(k) clearance for the 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)). This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 10, 2024, 156 days after receiving the submission on November 6, 2023.
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 | K233561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2023 |
| Decision Date | April 10, 2024 |
| Days to Decision | 156 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. |