# Novadaq Technologies, Inc.

- Location (FDA's records): Mississauga, Ontario, CA
- FDA decisions: 16 (1996–2017): 15 510(k) clearances and 1 original PMA approval
- Product codes: IZI (9), GCJ (3), FED (1), LLZ (1), OWN (1), MRK (1)
- 510(k) review time since 2016: median 86 days, against 99 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 59 (36 its own); citations of its devices by later devices: 65 (36 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Leica Microsystems, Inc.: 6 (https://510kreport.com/company/leica-microsystems)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- United States Endoscopy Group, Inc.: 1 (https://510kreport.com/company/united-states-endoscopy-group)
- Usgi Medical: 1 (https://510kreport.com/company/usgi-medical)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- American Radiologist Network, Inc.: 1 (https://510kreport.com/company/american-radiologist-network)
- Siemens Medical Solutions: 1 (https://510kreport.com/company/siemens-medical-solutions)

## Firms that cite its devices most
- Novadaq Technologies Ulc. (Now A Part of Stryker): 7 (https://510kreport.com/company/novadaq-technologies-ulc-now-a-part-of-stryker)
- Carl Zeiss Surgical GmbH: 7 (https://510kreport.com/company/carl-zeiss-surgical)
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- Visionsense, Ltd.: 2 (https://510kreport.com/company/visionsense)
- Leica Microsystems (Schweiz) AG: 2 (https://510kreport.com/company/leica-microsystems-schweiz)
- Mivenion GmbH: 2 (https://510kreport.com/company/mivenion)
- Hamamatsu Photonics K.K.: 2 (https://510kreport.com/company/hamamatsu-photonics)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)

## Its most-cited devices
- K042961: Spy Intra-Operative Imaging System: SP2000 (2005), cited by 11
- K063345: Spy Imaging System (2007), cited by 8
- K060867: Spy Intraoperative Imaging System (2006), cited by 8
- K071037: Spy Intra-Operative Imaging System, Model SP2000 (2007), cited by 7
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), cited by 5
- K072222: Spy Fluorescent Imaging System (2007), cited by 5

## Recent decisions
- K162885: SPY Phi Open Field Handheld Fluorescence Imaging System (Jan 11, 2017)
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (Sep 20, 2016)
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (May 23, 2016)
- K123013: Endoscopic Introducer (Mar 22, 2013)
- K100371: Spy Intra-Operative Imaging System (Feb 4, 2011)
- K091515: Spy Scope Intra-Operative Operating System (Jul 9, 2009)
- K081792: Spy Analysis Toolkit, Model SA9000 (Sep 17, 2008)
- K073130: Spy Fluorescent Imaging System (Jan 10, 2008)

Source page: https://510kreport.com/company/novadaq-technologies