Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Novadaq Technologies, Inc. — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

82 daysmedian FDA review time
357 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017-01-11860
K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016-09-20820
K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016-05-234100
K123013ENDOSCOPIC INTRODUCERNovadaq Technologies, Inc.2013-03-221750
K100371SPY INTRA-OPERATIVE IMAGING SYSTEMNovadaq Technologies, Inc.2011-02-043570
K091515SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEMNovadaq Technologies, Inc.2009-07-09480
K081792SPY ANALYSIS TOOLKIT, MODEL SA9000Novadaq Technologies, Inc.2008-09-17840
K073130SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc.2008-01-10650
K073088SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc.2008-01-10700
K071619SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc.2007-11-091492
K072222SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc.2007-09-07280
K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000Novadaq Technologies, Inc.2007-05-10280
K063345SPY IMAGING SYSTEMNovadaq Technologies, Inc.2007-01-12670
K060867SPY INTRAOPERATIVE IMAGING SYSTEMNovadaq Technologies, Inc.2006-05-03340
K042961SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000Novadaq Technologies, Inc.2005-01-19840

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda