# Novadaq Technologies Ulc. (Now A Part of Stryker)

- Location (FDA's records): Burnaby, CA
- FDA decisions: 6 (2018–2020): 6 510(k) clearances
- Product codes: OWN (4), IZI (1), GCJ (1)
- 510(k) review time since 2016: median 61 days, against 81 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 13 (6 its own); citations of its devices by later devices: 23 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novadaq Technologies, Inc.: 7 (https://510kreport.com/company/novadaq-technologies)

## Firms that cite its devices most
- Novadaq Technologies Ulc (A Part of Stryker): 2 (https://510kreport.com/company/novadaq-technologies-ulc-a-part-of-stryker)
- Guangdong Optomedic Technologies, Inc.: 2 (https://510kreport.com/company/guangdong-optomedic-technologies)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Onlume, Inc.: 1 (https://510kreport.com/company/onlume)
- Zhuhai Dipu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-dipu-medical-technology)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Arthex, Inc.: 1 (https://510kreport.com/company/arthex)

## Its most-cited devices
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), cited by 12
- K182907: SPY Elite Intraoperative Perfusion Assessment System (2019), cited by 4
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), cited by 4
- K190729: SPY Portable Handheld Imaging (SPY-PHI) System (2019), cited by 1
- K192174: SPY Portable Handheld Imaging (SPY-PHI) System (2019), cited by 1
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software (2020), cited by 1

## Recent decisions
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software (Nov 5, 2020)
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (May 21, 2020)
- K192174: SPY Portable Handheld Imaging (SPY-PHI) System (Nov 15, 2019)
- K190729: SPY Portable Handheld Imaging (SPY-PHI) System (Apr 19, 2019)
- K182907: SPY Elite Intraoperative Perfusion Assessment System (Jan 23, 2019)
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (Nov 21, 2018)

Source page: https://510kreport.com/company/novadaq-technologies-ulc-now-a-part-of-stryker