Cleared Traditional

K002942 - PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING (FDA 510(k) Clearance)

K002942 · Philips Medical Systems North America, Inc. · Radiology device

Dec 2000

Decision

89d

Days

Class 2

Risk

K002942 is an FDA 510(k) clearance for the PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING. 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 December 19, 2000, 89 days after receiving the submission on September 21, 2000.

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

Submission Details

510(k) Number	K002942 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 21, 2000
Decision Date	December 19, 2000
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF