Quantitative Vascular Angiography - CMS

Q: What is the product code of K023970?

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) K023970 · Medis Medical Imaging Systems BV

Substantially Equivalent

510(k) numberK023970

Submission

Device name: Quantitative Vascular Angiography - CMS
Applicant: Medis Medical Imaging Systems BV
Leiden, NL
Received: November 29, 2002
Decision date: January 24, 2003
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 Quantitative Vascular Angiography - CMS cleared by the FDA?

Quantitative Vascular Angiography - CMS (K023970) received a 510(k) decision of Substantially Equivalent on January 24, 2003, 56 days after the submission was received.

What is the product code of K023970?

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