Cleared Traditional

K121303 - MOBILE C-ARM (FDA 510(k) Clearance)

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

K121303 · Canon Inc. -Medical Equipment Group · Radiology device
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Jul 2012
Decision
86d
Days
Class 2
Risk

K121303 is an FDA 510(k) clearance for the MOBILE C-ARM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Canon Inc. -Medical Equipment Group (Richardson, US). The FDA issued a Cleared decision on July 26, 2012 after a review of 86 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 Canon Inc. -Medical Equipment Group devices

Submission Details

510(k) Number K121303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2012
Decision Date July 26, 2012
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
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 80
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