K192174 is an FDA 510(k) clearance for the SPY Portable Handheld Imaging (SPY-PHI) System. This device is classified as a Confocal Optical Imaging (Class II - Special Controls, product code OWN).
Submitted by Novadaq Technologies Ulc. (Now A Part of Stryker) (Burnaby, CA). The FDA issued a Cleared decision on November 15, 2019, 95 days after receiving the submission on August 12, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. Collection Of Light Signals For Visualization Of Cellular Microstructures..
| 510(k) Number | K192174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWN — Confocal Optical Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Collection Of Light Signals For Visualization Of Cellular Microstructures. |