Philips Easy Vision Family Workstation Option Cardirac Scoring

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002942 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Philips Medical Systems North America, Inc. →

• What is the primary function of the Philips Easy Vision Family Workstation Option Cardiac Scoring?

  This device is a specialized imaging workstation designed to assist clinicians in the analysis, scoring, and interpretation of cardiac images. It provides the necessary tools to aid in the diagnosis and treatment planning for patients with cardiovascular conditions.

• What is the regulatory status of this workstation?

  The Philips Easy Vision Family Workstation Option Cardiac Scoring has received FDA 510(k) clearance under K002942. This indicates that the device has been found substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of this cardiac imaging workstation?

  This device is manufactured by Philips Medical Systems North America, Inc., located in Shelton, Connecticut.