Cleared Traditional

K122589 - DFP4343C7

K122589 is an FDA 510(k) clearance for DFP4343C7, manufactured by Mdi Consultants, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K122589 · Mdi Consultants, Inc. · Radiology device
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Oct 2012
Decision
42d
Days
Class 2
Risk

K122589 is an FDA 510(k) clearance for the DFP4343C7. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Mdi Consultants, Inc. (Great Neck, US). The FDA issued a Cleared decision on October 5, 2012 after a review of 42 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 Mdi Consultants, Inc. devices

FDA 510(k) Submission Details - K122589

510(k) Number K122589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2012
Decision Date October 05, 2012
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
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 205
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