Cleared Traditional

K152244 - RADspeed Pro

K152244 is the FDA 510(k) clearance for RADspeed Pro by Shimadzu Corporation. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K152244 · Shimadzu Corporation · Radiology device
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Jun 2016
Decision
315d
Days
Class 2
Risk

K152244 is an FDA 510(k) clearance for the RADspeed Pro. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Shimadzu Corporation (Kyoto, JP). The FDA issued a Cleared decision on June 20, 2016 after a review of 315 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.

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Submission Details

510(k) Number K152244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date June 20, 2016
Days to Decision 315 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
208d slower than avg
Panel avg: 107d · This submission: 315d
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.

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