K182907 is an FDA 510(k) clearance for the SPY Elite Intraoperative Perfusion Assessment System. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Novadaq Technologies Ulc. (Now A Part of Stryker) (Burnaby, CA). The FDA issued a Cleared decision on January 23, 2019, 98 days after receiving the submission on October 17, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K182907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2018 |
| Decision Date | January 23, 2019 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |