Cleared Traditional

K003459 - PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW (FDA 510(k) Clearance)

K003459 · Philips Medical Systems North America, Inc. · Radiology device

Jan 2001

Decision

76d

Days

Class 2

Risk

K003459 is an FDA 510(k) clearance for the PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on January 22, 2001, 76 days after receiving the submission on November 7, 2000.

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

Submission Details

510(k) Number	K003459 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 07, 2000
Decision Date	January 22, 2001
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF