Cleared Special

K161285 - Ablation Confirmation

K161285 is an FDA 510(k) clearance for Ablation Confirmation, manufactured by Neuwave Medical, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 51-day FDA review.

K161285 · Neuwave Medical, Inc. · Radiology device
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Jun 2016
Decision
51d
Days
Class 2
Risk

K161285 is an FDA 510(k) clearance for the Ablation Confirmation. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Neuwave Medical, Inc. (Madision, US). The FDA issued a Cleared decision on June 29, 2016 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neuwave Medical, Inc. devices

FDA 510(k) Submission Details - K161285

510(k) Number K161285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2016
Decision Date June 29, 2016
Days to Decision 51 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

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 636
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