Cleared Traditional

K060344 - O-ARM IMAGING SYSTEM

K060344 is an FDA 510(k) clearance for O-ARM IMAGING SYSTEM, manufactured by Breakaway Imaging, LLC. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K060344 · Breakaway Imaging, LLC · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
47d
Days
Class 2
Risk

K060344 is an FDA 510(k) clearance for the O-ARM IMAGING SYSTEM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Breakaway Imaging, LLC (Littleton, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 47 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Breakaway Imaging, LLC devices

FDA 510(k) Submission Details - K060344

510(k) Number K060344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2006
Decision Date March 29, 2006
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 49
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K060344.
OEC Elite MiniView
K171800 · Ge Hualun Medical Systems Co. , Ltd. · Jul 2017
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · Hologic, Inc. · Apr 2012
VERT-X
K061873 · Direx Systems Corp. · Aug 2006
ARCADIS AVANTIC
K051133 · Siemens Medical Solutions USA, Inc. · Jun 2005
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K043379 · Shimadzu Corp. · Feb 2005
3DSCOPE
K041213 · Direx Systems Corp. · Jul 2004