The following data is part of a premarket notification filed by Novadaq Technologies Inc. with the FDA for Pinpoint Endoscopic Fluorescence Imaging System.
| Device ID | K161792 |
| 510k Number | K161792 |
| Device Name: | PINPOINT Endoscopic Fluorescence Imaging System |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-06-30 |
| Decision Date | 2016-09-20 |
| Summary: | summary |