Philips Integris V3000 Rotational Angio Function

FDA 510(k) K923813 · Philips Medical Systems, Inc.

Substantially Equivalent

510(k) numberK923813

Submission

Device name
Philips Integris V3000 Rotational Angio Function
Applicant
Philips Medical Systems, Inc.
5680 Da Best, NL
Received
July 29, 1992
Decision date
October 16, 1992
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 V3000 Rotational Angio Function cleared by the FDA?

Philips Integris V3000 Rotational Angio Function (K923813) received a 510(k) decision of Substantially Equivalent on October 16, 1992, 79 days after the submission was received.

What is the product code of K923813?

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