Cleared Special

K033066 - XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM

K033066 is an FDA 510(k) clearance for XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM, manufactured by Xitec Holdings, LLC. The device is a Class 2 Radiology device with product code OXO cleared through the Special 510(k) pathway after a 44-day FDA review.

K033066 · Xitec Holdings, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
44d
Days
Class 2
Risk

K033066 is an FDA 510(k) clearance for the XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Xitec Holdings, LLC (North Attleboro, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033066

510(k) Number K033066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 12, 2003
Days to Decision 44 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 81
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K033066.
3DSCOPE
K041213 · Direx Systems Corp. · Jul 2004
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K040347 · Siemens Medical Systems, Inc. · Mar 2004
SIREMOBILE C06
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MOONRAY MOBILE C-ARM
K013426 · Simad S.R.L. · Mar 2002
PHILIPS BV LIBRA
K010762 · Philips Medical Systems, Inc. · Apr 2001
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
K003837 · Ge Oec Medical Systems · Mar 2001
K033066 · XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
Download PDF FDA Summary Xitec Holdings, LLC