Cleared Abbreviated

K050996 - O-ARM IMAGING SYSTEM

K050996 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 Abbreviated 510(k) pathway after a 15-day FDA review.

K050996 · Breakaway Imaging, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
15d
Days
Class 2
Risk

K050996 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 May 5, 2005 after a review of 15 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K050996

510(k) Number K050996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date May 05, 2005
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K050996.
ORTHOSCAN, ORTHOSCAN HD
K051754 · Orthoscan, Inc. · Aug 2005
GE OEC EVERVIEW 7500
K051490 · Ge Oec Medical Systems, Inc. · Jul 2005
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
SIREMOBIL ISO-C 3D
K040347 · Siemens Medical Systems, Inc. · Mar 2004
K050996 · O-ARM IMAGING SYSTEM
Download PDF FDA Summary Breakaway Imaging, LLC