K181534 is an FDA 510(k) clearance for the CIRRUS HD-OCT. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on February 15, 2019, 249 days after receiving the submission on June 11, 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 | K181534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2018 |
| Decision Date | February 15, 2019 |
| Days to Decision | 249 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. |