Cleared Traditional

K153119 - Amrad Medical OTS Digital Radiography S...

K153119 is the FDA 510(k) clearance for Amrad Medical OTS Digital Radiography S... by Summit Industries, LLC. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K153119 · Summit Industries, LLC · Radiology device
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Mar 2016
Decision
137d
Days
Class 2
Risk

K153119 is an FDA 510(k) clearance for the Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Rad.... Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Summit Industries, LLC (Chicago, US). The FDA issued a Cleared decision on March 14, 2016 after a review of 137 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Summit Industries, LLC devices

Submission Details

510(k) Number K153119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2015
Decision Date March 14, 2016
Days to Decision 137 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
30d slower than avg
Panel avg: 107d · This submission: 137d
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

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