The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Spy Fluorescent Imaging System.
| Device ID | K071619 |
| 510k Number | K071619 |
| Device Name: | SPY FLUORESCENT IMAGING SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario, CA L4w 4l5 |
| Contact | Allison Manners |
| Correspondent | Allison Manners NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario, CA L4w 4l5 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-06-13 |
| Decision Date | 2007-11-09 |
| Summary: | summary |