Cleared Traditional

K133959 - PODIATRY X-RAY SYSTEM

K133959 is the FDA 510(k) clearance for PODIATRY X-RAY SYSTEM by Source-Ray, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K133959 · Source-Ray, Inc. · Radiology device
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Jan 2015
Decision
394d
Days
Class 2
Risk

K133959 is an FDA 510(k) clearance for the PODIATRY X-RAY SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Source-Ray, Inc. (Ronkonkoma, US). The FDA issued a Cleared decision on January 22, 2015 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Source-Ray, Inc. devices

Submission Details

510(k) Number K133959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2013
Decision Date January 22, 2015
Days to Decision 394 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 107d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 172
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