Cleared Traditional

K113708 - ORTHOSCAN MOBILE DI MINI C-ARM

K113708 is an FDA 510(k) clearance for ORTHOSCAN MOBILE DI MINI C-ARM, manufactured by Orthoscan, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K113708 · Orthoscan, Inc. · Radiology device
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Jan 2012
Decision
20d
Days
Class 2
Risk

K113708 is an FDA 510(k) clearance for the ORTHOSCAN MOBILE DI MINI C-ARM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on January 5, 2012 after a review of 20 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 Orthoscan, Inc. devices

FDA 510(k) Submission Details - K113708

510(k) Number K113708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2011
Decision Date January 05, 2012
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

Intertek Testing Services
WILLIAM SAMMONS

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 69
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