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Philips Cardiac Workstation

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922622

by Philips Medical Systems, Inc.

Identifiers

510(k) Number
K922622 FDA 510(k)
FDA Product Code
IZI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1600 FDA 510(k)
Regulation Number
892.1600 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Philips Cardiac Workstation is a system, X-ray, angiographic device classified under radiology. It is a substantially equivalent device cleared via the traditional 510(k) pathway.

It is supplied by Philips Medical Systems, Inc. and is authorized under FDA 510(k) clearance K922622. The device is intended for use in radiology settings and is regulated under regulation number 892.1600 with product code IZI.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardiac Workstation 5000 - Philips, Philips recalls Cardiac Workstation systems due to software issue—users ..., Global home | Philips

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K922622 24 fields · synced Sep 19, 2026