Cleared Traditional

PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING

K002942 · Philips Medical Systems North America, Inc. · Radiology
Dec 2000
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K002942 is an FDA 510(k) clearance for the PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING, 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 review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K002942 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050