Cleared Special

K040066 - SIREMOBILE C06

K040066 is an FDA 510(k) clearance for SIREMOBILE C06, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Special 510(k) pathway after a 30-day FDA review.

K040066 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K040066

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
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 K040066.
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K043379 · Shimadzu Corp. · Feb 2005
3DSCOPE
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SIREMOBIL ISO-C 3D
K040347 · Siemens Medical Systems, Inc. · Mar 2004
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K033066 · Xitec Holdings, LLC · Nov 2003
MOONRAY MOBILE C-ARM
K013426 · Simad S.R.L. · Mar 2002
PHILIPS BV LIBRA
K010762 · Philips Medical Systems, Inc. · Apr 2001
K040066 · SIREMOBILE C06
Download PDF FDA Summary Siemens Medical Solut…