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Xiscan Office Expert Imaging System, Xiscan Surgical Expert Imaging System

by Xitec, Inc.

510(k) K984406

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984406 Date2 Feb 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OXO
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is an image-intensified fluoroscopic X-ray system, mobile, as defined in the device data. It is substantially equivalent to a predicate device and cleared under the traditional 510(k) pathway.

It is supplied by Xitec, Inc., located at 49 Plain St., North Attleboro, MA 02760, United States. The device received FDA 510(k) clearance on February 2, 1999, under K984406, with product code OXO and regulation number 892.1650. It is classified as a Class II medical device.

Other devices from Xitec, Inc.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the XISCAN Office Expert Imaging System used for?

    The XISCAN Office Expert Imaging System is an image-intensified fluoroscopic X-ray system designed for mobile use in clinical settings, providing real-time imaging during procedures as a substantially equivalent device to its predicate under FDA 510(k) clearance.

  • How is the XISCAN Office Expert Imaging System supplied and by whom?

    The device is supplied by Xitec, Inc., located at 49 Plain St., North Attleboro, MA 02760, United States, and was cleared for distribution following its FDA 510(k) submission.

  • When did the XISCAN Office Expert Imaging System receive FDA clearance and under what pathway?

    The device received FDA 510(k) clearance on February 2, 1999, under submission K984406 via the traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device.