Cleared Special

K040066 - SIREMOBILE C06 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K040066 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
30d
Days
Class 2
Risk

K040066 is an FDA 510(k) clearance for the SIREMOBILE C06. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on February 12, 2004 after a review of 30 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.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K040066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2004
Decision Date February 12, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 80
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K040066.
Orthoscan TAU MVP Mini C-Arm System
K252579 · Ziehm-Orthoscan, Inc. · Jan 2026
OEC One CFD
K253269 · Ge Hualun Medical Systems Co. , Ltd. · Nov 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004 · Hefei Chimed Intelligent Machine Co., Ltd. · Nov 2025
Orthoscan TAU Mini C-Arm
K250587 · Ziehm-Orthoscan, Inc. · Jul 2025
Orthoscan VERSA Mini C-Arm
K243452 · Ziehm-Orthoscan, Inc. · Jan 2025
OEC One ASD
K240828 · Ge Hualun Medical Systems Co. , Ltd. · Dec 2024