Cleared Traditional

K173823 - Amrad Medical AAU Digital Radiography S...

Also marketed or referenced as:
Amrad Medical AAU Plus Digital Radiography System Amrad Medical DFMT Digital Radiography System Amrad Medical FMT Digital Radiography System

K173823 is the FDA 510(k) clearance for Amrad Medical AAU 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 53-day FDA review.

K173823 · Summit Industries, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
53d
Days
Class 2
Risk

K173823 is an FDA 510(k) clearance for the Amrad Medical AAU Digital Radiography System. 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 February 9, 2018 after a review of 53 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 Summit Industries, LLC devices

Submission Details

510(k) Number K173823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2017
Decision Date February 09, 2018
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
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 Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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