Cleared Traditional

O-ARM IMAGING SYSTEM (K060344) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060344 · Breakaway Imaging, LLC · Radiology device
Download Printable Device Report (PDF)
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

Submission Details

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.

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 22
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K060344.
Smart-C
K190024 · Turner Imaging Systems, Inc. · Sep 2019
OrthoScan TAU Mini C-Arm
K183220 · Orthoscan, Inc. · Jun 2019
OEC One
K182626 · Ge Hualun Medical Systems Co. , Ltd. · Nov 2018
ARCADIS AVANTIC
K051133 · Siemens Medical Solutions USA, Inc. · Jun 2005
SIREMOBILE C06
K040066 · Siemens Medical Solutions USA, Inc. · Feb 2004
SIREMOBIL ISO-C 3D
K003266 · Siemens Medical Solutions USA, Inc. · Dec 2000