Cleared Traditional

K100371 - SPY INTRA-OPERATIVE IMAGING SYSTEM

K100371 is an FDA 510(k) clearance for SPY INTRA-OPERATIVE IMAGING SYSTEM, manufactured by Novadaq Technologies, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K100371 · Novadaq Technologies, Inc. · Radiology device
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Feb 2011
Decision
357d
Days
Class 2
Risk

K100371 is an FDA 510(k) clearance for the SPY INTRA-OPERATIVE IMAGING SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Novadaq Technologies, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on February 4, 2011 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Novadaq Technologies, Inc. devices

FDA 510(k) Submission Details - K100371

510(k) Number K100371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date February 04, 2011
Days to Decision 357 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 107d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZI System, X-ray, Angiographic

All 102
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