K190729 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 April 19, 2019, 29 days after receiving the submission on March 21, 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 | K190729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | March 21, 2019 |
| Decision Date | April 19, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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. |