K190772 is an FDA 510(k) clearance for the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 10, 2019, 198 days after receiving the submission on March 26, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K190772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2019 |
| Decision Date | October 10, 2019 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |