Dynact

FDA 510(k) K042646 · Siemens Medical Systems, Inc.

Substantially Equivalent

510(k) numberK042646

Submission

Device name
Dynact
Applicant
Siemens Medical Systems, Inc.
Mavern, PA, US
Received
September 28, 2004
Decision date
October 19, 2004
Decision
Substantially Equivalent (SESE)
Type
Special 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 Dynact cleared by the FDA?

Dynact (K042646) received a 510(k) decision of Substantially Equivalent on October 19, 2004, 21 days after the submission was received.

What is the product code of K042646?

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