Cleared Abbreviated

K092564 - O-ARM IMAGING SYSTEM

K092564 is an FDA 510(k) clearance for O-ARM IMAGING SYSTEM, manufactured by Medtronic Navigation, Inc. (Littleton). The device is a Class 2 Radiology device with product code OXO cleared through the Abbreviated 510(k) pathway after a 301-day FDA review.

K092564 · Medtronic Navigation, Inc. (Littleton) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
301d
Days
Class 2
Risk

K092564 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 Medtronic Navigation, Inc. (Littleton) (Littleton, US). The FDA issued a Cleared decision on June 17, 2010 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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.

View all Medtronic Navigation, Inc. (Littleton) devices

FDA 510(k) Submission Details - K092564

510(k) Number K092564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date June 17, 2010
Days to Decision 301 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 107d · This submission: 301d
Pathway characteristics
Standards-based clearance path.

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 65
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K092564.
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · Hologic, Inc. · Apr 2012
OEC 9900 ELITE
K120613 · Ge Healthcare Surgery GE Oec Medical Systems, Inc. · Apr 2012
ORTHOSCAN MOBILE DI MINI C-ARM
K113708 · Orthoscan, Inc. · Jan 2012
VERT-X
K061873 · Direx Systems Corp. · Aug 2006
O-ARM IMAGING SYSTEM
K060344 · Breakaway Imaging, LLC · Mar 2006
ORTHOSCAN, ORTHOSCAN HD
K051754 · Orthoscan, Inc. · Aug 2005