Cleared Special

K041213 - 3DSCOPE

K041213 is an FDA 510(k) clearance for 3DSCOPE, manufactured by Direx Systems Corp.. The device is a Class 2 Radiology device with product code OXO cleared through the Special 510(k) pathway after a 73-day FDA review.

K041213 · Direx Systems Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
73d
Days
Class 2
Risk

K041213 is an FDA 510(k) clearance for the 3DSCOPE. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Direx Systems Corp. (Natick, US). The FDA issued a Cleared decision on July 22, 2004 after a review of 73 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Direx Systems Corp. devices

FDA 510(k) Submission Details - K041213

510(k) Number K041213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date July 22, 2004
Days to Decision 73 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K041213.
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