Cleared Traditional

K062650 - EP NAVIGATOR SOFTWARE (FDA 510(k) Clearance)

K062650 · Philips Medical Systems · Radiology device

Sep 2006

Decision

14d

Days

Class 2

Risk

K062650 is an FDA 510(k) clearance for the EP NAVIGATOR SOFTWARE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems (Bothell, US). The FDA issued a Cleared decision on September 21, 2006, 14 days after receiving the submission on September 7, 2006.

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

Submission Details

510(k) Number	K062650 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 07, 2006
Decision Date	September 21, 2006
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF