The Midview-Medcon's Dicom Viewer

Q: What is the product code of K971181?

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) K971181 · Medcon , Ltd.

Substantially Equivalent

510(k) numberK971181

Submission

Device name: The Midview-Medcon's Dicom Viewer
Applicant: Medcon , Ltd.
Efrat, IL
Received: March 31, 1997
Decision date: July 29, 1997
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 The Midview-Medcon's Dicom Viewer cleared by the FDA?

The Midview-Medcon's Dicom Viewer (K971181) received a 510(k) decision of Substantially Equivalent on July 29, 1997, 120 days after the submission was received.

What is the product code of K971181?

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