Cleared Traditional

SPY INTRA-OPERATIVE IMAGING SYSTEM (K100371) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 36
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K100371.
SPY Elite Intraoperative Perfusion Assessment System
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GLOW800
K181537 · Leica Microsystems (Schweiz) AG · Sep 2018
CAAS Workstation
K180019 · Pie Medical Imaging BV · May 2018
ARTIS ZEE / ZEEGOS WITH SW VC14
K090745 · Siemens Medical Solutions USA, Inc. · Jun 2009
ARTIS ZEE AND ZEEGO
K073290 · Siemens Medical Solutions USA, Inc. · Feb 2008
DIGITAL IMAGING SYSTEM (BSR)
K991922 · Siemens Medical Solutions USA, Inc. · Sep 1999