510(k) Report

510(k) · Cleared

Cleared

Xiscan 4000 Transportable Imaging System

K033066510(k) SpecialCleared Nov 12, 200344-day reviewClass II21 CFR 892.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Xitec Holdings, LLC · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

Cleared on Nov 12, 2003 as substantially equivalent to K003568 (Xitec, Inc., 2000) after a 44-day review. Its family tree reaches back 1 generation to 2000.

Decided
Nov 12, 2003
Review
44 days
Class
Class II
Product code
OXO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003568 (2000). No later device cites it as a predicate yet.

K003568 · Xiscan 6000 Imaging System · Xitec, Inc. · 2000200020022004
K003568 · Xiscan 6000 Imaging System · Xitec, Inc. · 20000
  1. Root · 1 generation backK003568 Xiscan 6000 Imaging SystemXitec, Inc. · 2000
  2. This deviceK033066 Xiscan 4000 Transportable Imaging SystemXitec Holdings, LLC · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003568Xiscan 6000 Imaging SystemXitec, Inc.2000—
0 (this device)K033066Xiscan 4000 Transportable Imaging SystemXitec Holdings, LLC2003—
FIG. 1 — Lineage of K033066, 2000–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OXO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OXO device

  1. #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003568Xiscan 6000 Imaging System
Summary page 1
…scopic mini C-arm systems Classification Name: Image-intensified fluoroscopic X-ray system 3. PREDICATE DEVICE XiScan 6000 Imaging System (K003568) 4. INTENDED USE The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient e…
Xitec, Inc.2000—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All OXO devices

OXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OXO

4in 2025

2010: 12012: 42013: 22014: 22015: 12016: 32017: 42018: 12019: 32021: 22024: 22025: 42026 (partial year): 2
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXO

97in 2025

2012: 48 days median2016: 128 days median2017: 57 days median2019: 213 days median2025: 97 days median
2007high 213 (2019) · low 48 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OXO

4in 2024

2012: 42013: 32014: 42016: 32017: 42018: 112024: 42026 (partial year): 1
2007high 11 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OXO

118in 2025

2012: 52013: 412014: 892015: 972016: 3,8202017: 1,6972018: 1,6472019: 1,2972020: 8162021: 5542022: 2952023: 2752024: 1922025: 118
2007high 3,820 (2016) · low 0 (2007)2025

MAUDE reports naming product code OXO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
201244845
20132—341
20142—489
20151—097
2016312833,820
201745741,697
20181—111,647
2019321301,297
20200—0816
20212—0554
20220—0295
20230—0275
20242—4192
20254970118
20262—1—

What is it indicated for?

The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

Indications for use as stated in the FDA summary.

Recent decisions in OXO

The OXO category page

  • K253296Digital C-ARM with 3DAllengers Medical Systems Limited · 2026
  • K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
  • K253269OEC One CFDGe Hualun Medical Systems Co., Ltd. · 2025
  • K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd. · 2025
  • K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc. · 2025

https://510kreport.com/device/K033066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033066: Xiscan 4000 Transportable Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033066

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026