Cleared Traditional

K192174 - SPY Portable Handheld Imaging (SPY-PHI)...

K192174 is the FDA 510(k) clearance for SPY Portable Handheld Imaging (SPY-PHI)... by Novadaq Technologies Ulc. (Now A Part of Stryker). It is a Class 2 General & Plastic Surgery device (product code OWN) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K192174 · Novadaq Technologies Ulc. (Now A Part of Stryker) · General & Plastic Surgery device
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Nov 2019
Decision
95d
Days
Class 2
Risk

K192174 is an FDA 510(k) clearance for the SPY Portable Handheld Imaging (SPY-PHI) System. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Novadaq Technologies Ulc. (Now A Part of Stryker) (Burnaby, CA). The FDA issued a Cleared decision on November 15, 2019 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Novadaq Technologies Ulc. (Now A Part of Stryker) devices

Submission Details

510(k) Number K192174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2019
Decision Date November 15, 2019
Days to Decision 95 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWN Confocal Optical Imaging

All 42
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K192174.
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K192292 · Stryker · Nov 2019
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K191046 · Stryker · May 2019
SPY Portable Handheld Imaging (SPY-PHI) System
K190729 · Novadaq Technologies Ulc. (Now A Part of Stryker) · Apr 2019
VS3-IR
K183453 · Medtronic · Mar 2019