Philips Integris 3D Ra Option

Q: What is the product code of K983877?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.

FDA 510(k) K983877 · Philips Medical Systems North America, Inc.

Substantially Equivalent

510(k) numberK983877

Submission

Device name: Philips Integris 3D Ra Option
Applicant: Philips Medical Systems North America, Inc.
Shelton, CT, US
Received: November 2, 1998
Decision date: December 21, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IZI – System, X-Ray, Angiographic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1600
Specialty: Radiology

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Questions and answers

When was Philips Integris 3D Ra Option cleared by the FDA?

Philips Integris 3D Ra Option (K983877) received a 510(k) decision of Substantially Equivalent on December 21, 1998, 49 days after the submission was received.

What is the product code of K983877?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.