SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies Ulc (A Part of Stryker)
Novadaq Technologies ULC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012345110 | 3012345110 | Novadaq Technologies ULC | 1 | N | 2026-01-01 | 8329 Eastlake Drive, Unit 101 Burnaby British Columbia CA V5A 4W2 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 214918 | 1180223719 | K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | IZI | 2023-06-05 |
| 214918 | 2018473514 | K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | OWN | 2020-11-05 |
| 214918 | 1602754692 | K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2020-05-21 |
| 214918 | 1596579836 | K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2019-11-15 |
| 214918 | 1722338774 | K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | OWN | 2019-04-19 |
| 214918 | 1333740599 | K182907 | SPY Elite Intraoperative Perfusion Assessment System | IZI | 2019-01-23 |
| 214918 | 1945559014 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2018-11-21 |
| 214918 | 2002447612 | K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | OWN | 2017-01-11 |
| 214918 | 1574158689 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2016-09-20 |
| 214918 | 1760970190 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | GCJ | 2016-05-23 |
| 214918 | 1782791944 | K123013 | ENDOSCOPIC INTRODUCER | FED | 2013-03-22 |
| 214918 | 1057692963 | K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | IZI | 2011-02-04 |
| 214918 | 1687550856 | K091515 | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM | GCJ | 2009-07-09 |
| 214918 | 1679040848 | K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 | LLZ | 2008-09-17 |
| 214918 | 1930050302 | K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | FRG | 2008-12-05 |
| 214918 | 1427089939 | K073130 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2008-01-10 |
| 214918 | 1603109420 | K073088 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2008-01-10 |
| 214918 | 1581970423 | K072222 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2007-09-07 |
| 214918 | 1101350139 | K071619 | SPY FLUORESCENT IMAGING SYSTEM | IZI | 2007-11-09 |
| 214918 | 1878693082 | K071037 | SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 | IZI | 2007-05-10 |
| 214918 | 1055135084 | K022978 | STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS | FRG | 2003-05-09 |
| 214918 | 1106735739 | ||||
| 214918 | 1193589410 | ||||
| 214918 | 1262446897 | ||||
| 214918 | 1647782873 | ||||
| 214918 | 1675925506 | ||||
| 214918 | 1893696672 | ||||
| 214918 | 1899259454 | ||||
| 214918 | 1998545341 |
Product Codes Associated With Registrations
PMN
SPY-PHI System With SPY-PHI Fluorescence Assessment Software
Novadaq Technologies ULC (now A Part Of Stryker)
SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC. (now A Part Of Stryker)
SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC. (now A Part Of Stryker)
SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC. (now A Part Of Stryker)
SPY Elite Intraoperative Perfusion Assessment System
Novadaq Technologies ULC. (now A Part Of Stryker)
PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies ULC (now A Part Of Stryker)