Philips Integris C2000 System

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

510(k) Number

K902542 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

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 Philips Integris C2000 System used for?

  The Philips Integris C2000 System is a sophisticated imaging device designed for use in interventional radiology. It is classified as a System, X-Ray, Angiographic device used in the medical specialty of Radiology.

• How is the Philips Integris C2000 System supplied?

  The Philips Integris C2000 System is supplied by Philips Medical Systems North America, Inc. It has been cleared through the FDA 510(k) pathway and is classified as a Class 2 device under product code IZI.

• What is the regulatory status of the Philips Integris C2000 System?

  The Philips Integris C2000 System has been cleared through the FDA 510(k) pathway with k number K902542. It is classified as a Class 2 device under product code IZI, with regulation number 892.1600.

• What is the decision description for the Philips Integris C2000 System?

  The decision description for the Philips Integris C2000 System is 'Substantially Equivalent.' This indicates that the device has been determined to be substantially equivalent to another legally marketed device.