Cleared Traditional

K150313 - Ablation Confirmation (FDA 510(k) Clearance)

K150313 · Neuwave Medical, Inc. · Radiology device

Jul 2015

Decision

150d

Days

Class 2

Risk

K150313 is an FDA 510(k) clearance for the Ablation Confirmation. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Neuwave Medical, Inc. (Madision, US). The FDA issued a Cleared decision on July 9, 2015, 150 days after receiving the submission on February 9, 2015.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K150313 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 2015
Decision Date	July 09, 2015
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF