Cleared Traditional

K122119 - DX-D FULL LEG FULL SPINE

K122119 is an FDA 510(k) clearance for DX-D FULL LEG FULL SPINE, manufactured by Afga Healthcare N.V.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K122119 · Afga Healthcare N.V. · Radiology device
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Sep 2012
Decision
58d
Days
Class 2
Risk

K122119 is an FDA 510(k) clearance for the DX-D FULL LEG FULL SPINE. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Afga Healthcare N.V. (Brevard, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Afga Healthcare N.V. devices

FDA 510(k) Submission Details - K122119

510(k) Number K122119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date September 13, 2012
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 193
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K122119.
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