Xiscan 6000 Imaging System

FDA 510(k) K003568 · Xitec, Inc.

Substantially Equivalent

510(k) numberK003568

Submission

Device name
Xiscan 6000 Imaging System
Applicant
Xitec, Inc.
North Attleboro, MA, US
Received
November 20, 2000
Decision date
December 27, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Fluoroscopy of the human body.

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More from Ge Oec Medical Systems, Inc.

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Questions and answers

When was Xiscan 6000 Imaging System cleared by the FDA?

Xiscan 6000 Imaging System (K003568) received a 510(k) decision of Substantially Equivalent on December 27, 2000, 37 days after the submission was received.

What is the product code of K003568?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.