Cleared Traditional

K170023 - SPiN Thoracic Navigation System

K170023 is an FDA 510(k) clearance for SPiN Thoracic Navigation System, manufactured by Veran Medical Technologies, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K170023 · Veran Medical Technologies, Inc. · Radiology device
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May 2017
Decision
132d
Days
Class 2
Risk

K170023 is an FDA 510(k) clearance for the SPiN Thoracic Navigation System. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Veran Medical Technologies, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 15, 2017 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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. Standard predicate reliance. 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 Veran Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K170023

510(k) Number K170023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date May 15, 2017
Days to Decision 132 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
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 640
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K170023.
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K162838 · Philips Medical Systems (Cleveland), Inc. · Apr 2017