The following data is part of a premarket notification filed by Novadaq Technologies Ulc. (now A Part Of Stryker) with the FDA for Spy Portable Handheld Imaging (spy-phi) System.
| Device ID | K192174 |
| 510k Number | K192174 |
| Device Name: | SPY Portable Handheld Imaging (SPY-PHI) System |
| Classification | Confocal Optical Imaging |
| Applicant | Novadaq Technologies ULC. (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a 4w2 |
| Contact | Agatha Szeliga |
| Correspondent | Agatha Szeliga Novadaq Technologies ULC. (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a 4w2 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-08-12 |
| Decision Date | 2019-11-15 |