510(k) Report

FDA applicant

Novadaq Technologies, Inc.

Mississauga, Ontario, CA16 decisions1996–20176 recalls

FDA records 16 decisions for Novadaq Technologies, Inc. (Mississauga, Ontario, CA) from 1996 to 2017: 15 510(k) clearances and 1 original PMA approval. Most are in product codes IZI (System, X-Ray, Angiographic) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 59 predicates, 36 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Novadaq Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 42008: 32009: 12011: 12013: 12016: 22017: 1
2007high 4 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2021

2014: 22016: 22020: 12021: 1
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Novadaq Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novadaq Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IZISystem, X-Ray, Angiographic9decisions
  • GCJLaparoscope, General & Plastic Surgery3decisions
  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision
  • LLZSystem, Image Processing, Radiological1decision
  • OWNConfocal Optical Imaging1decision
  • MRKSystem, Imaging, Fluorescence1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 59 predicates; 36 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 65 times; 36 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 200511cite it
  • K063345Spy Imaging SystemNovadaq Technologies, Inc. · 20078cite it
  • K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 20068cite it
  • K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 20077cite it
  • K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 20165cite it
  • K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 20075cite it

What has FDA decided for it lately?

  • K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc. · 20171 recall
  • K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
  • K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 20161 recall
  • K123013Endoscopic IntroducerNovadaq Technologies, Inc. · 2013
  • K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011
  • K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 20091 recall
  • K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc. · 2008
  • K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008

All 16 as Novadaq Technologies, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K150956Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical…Feb 26, 2021Class II
  • K162885Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI…Jan 7, 2020Class II
  • K042961Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY…Aug 18, 2016Class II
  • K091515PINPOINT Endoscopic Fluorescence Imaging SystemJan 29, 2016Class II
  • K071619Non-sterile drapeNov 4, 2014Class III
  • K071619LUNA Chest, Model No. LU4006Nov 4, 2014Class III

Other applicant names beginning “Novadaq”

FDA records each applicant name separately; these may or may not be the same firm.

Novadaq Technologies Ulc. (Now A Part of Stryker) 6Novadaq Technologies Ulc (A Part of Stryker) 1