Axiom Artis Modular Angiography System

FDA 510(k) K010721 · Siemens Medical Corp.

Substantially Equivalent

510(k) numberK010721

Submission

Device name
Axiom Artis Modular Angiography System
Applicant
Siemens Medical Corp.
Iselin, NJ, US
Received
March 12, 2001
Decision date
March 30, 2001
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 Axiom Artis Modular Angiography System cleared by the FDA?

Axiom Artis Modular Angiography System (K010721) received a 510(k) decision of Substantially Equivalent on March 30, 2001, 18 days after the submission was received.

What is the product code of K010721?

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