The following data is part of a premarket notification filed by Novadaq Technologies Inc. with the FDA for Spy Phi Open Field Handheld Fluorescence Imaging System.
| Device ID | K162885 |
| 510k Number | K162885 |
| Device Name: | SPY Phi Open Field Handheld Fluorescence Imaging System |
| Classification | Confocal Optical Imaging |
| Applicant | NOVADAQ TECHNOLOGIES INC. 8329 EASTLAKE DRIVE UNIT 101 Burnaby, CA V5a 4w2 |
| Contact | Jen Pendlebury |
| Correspondent | Jen Pendlebury NOVADAQ TECHNOLOGIES INC. 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 | 2016-10-17 |
| Decision Date | 2017-01-11 |
| Summary: | summary |