510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K033066Substantially Equivalent

Xiscan 4000 Transportable Imaging System

Xitec Holdings, LLC, North Attleboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033066 is the FDA 510(k) clearance record for XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM, a class II device, cleared for Xitec Holdings, LLC on under FDA product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile). FDA's definition for product code OXO reads: "Fluoroscopy of the human body". FDA records list one 510(k) clearance for Xitec Holdings, LLC. As of , FDA records show no recalls naming K033066.

Clearance record

Decision date
Received
(44 days to decision)
Product code
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Xitec Holdings, LLC 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXO

Trailing 12 months
4 clearances under product code OXO in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OXO, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260